Monarch IFU

Device Description

The Monarch Blood Collection Set is a single use, non-reusable, sterile device, with three configurations to include needle gauge sizes 21, 23, and 25. Each configuration includes a winged housing unit with a needle hub, flexible tubing, female luer connector, and an integrated male luer pre-connected to a holder, intended for use with blood collection tubes and/or blood culture bottles.

Sharps Prevention

The Monarch blood collection device contains a sharps injury prevention feature. Upon full needle retraction, the needle tube is trapped inside the device housing. The needle cannot be re-extended for re-use. Trapping of the needle tube is designed to prevent accidental needlesticks during normal handling and disposal.

Monarch Blood Collection Set
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Indications for Use:

The Monarch Blood Collection Set is a sterile, multi-sample, single use fixed winged blood collection set. The device is indicated for general medical use in Healthcare Facilities by medical professionals with the patient population to include both adolescent and adult patients. The Monarch Blood Collection Set is intended to be used with evacuated blood collection tubes and/or blood culture bottles. The Monarch Blood Collection device is to remain under direct supervision of a medical professional during use.

The Monarch Blood Collection set includes a safety feature to prevent accidental needlestick injury during normal handling and disposal. The safety feature is initiated by full manual retraction of the needle from the venipuncture site to prevent accidental needlesticks during handling and disposal.

The Monarch Blood Collection set is not intended for infusion, IV Administration, or transfusion.

Instructions for Use - Single Hand Activation Technique:

Step 1

Visually inspect kit and confirm there is no damage present (no tears/punctures). If packaging appears damaged – do not use and dispose of per facility policy/protocol.

Step 2

Step 2Peel blister pouch at marked location(s) and remove device from packaging.

Step 3

Visually inspect kit and confirm there is no damage present to device/equipment (no cracks or breaks). If device appears to be damaged – do not use and dispose/report per facility policy/protocol.

Step 4

The transfer device / holder (2) is pre-attached and secured to backend female luer (Step 41). Confirm by pushing the luer slip component of the transfer device (2) / holder into the back-end female luer adapter (1).

Step 5

Prepare venipuncture site per facility policy/protocol.

Step 6
Step 6Place index finger of predominant hand behind finger tab on top of the blood collection device.
Step 7

Step 7Remove Needle Cover while keeping index finger of predominant hand behind finger tab on top of the blood collection device. CAUTION: Care should be taken to avoid needle contact by user

Step 8

Step 8Perform venipuncture draw per facility policy/protocol.

Step 9

Step 9Collect blood into the vacuum tube by placing the vacuum tube (2) into the transfer device/holder (1) and pushing the center of 9 vacuum tube stopper over the needle inside the transfer device/holder (1). Additional tubes may be used as appropriate. Follow facility policy/protocol.

Step 10

Step 10Place gauze over the venipuncture site per facility policy/protocol.

Step 11

Step 11Place index finger of predominant hand on top of the finger tab on the blood collection device.

Step 12

Step 12Gently retract the finger tab towards the distal part of the device. Initially, a slight resistance will be felt as the needle retracts onto the hub of the device.

Step 13

Step 13Two “clicks” will be felt and heard. The first click is the door beginning to close and the second click is the safety mechanism engaging to trap the needle inside the device Housing to prevent accidental needlesticks.

Step 14

Step 14Apply digital pressure to the gauze and facility policy/protocol.

Step 15

Step 15Dispose in Sharps container following facility policy/protocol.

Precaution

  1. Misuse or mishandling of the device may result in exposure to blood or needlestick injury.
  2. Follow facility protocol standard for infection control procedure.
  3. This device is to be used by medical professionals only.
  4. Vacuum tubes may vary in diameter size. Adaptors should be used to ensure the proper puncture of the vacuum tube following institutional policy.
  5. The Monarch Safety Blood Collection Set is not intended for infusion, IV Administration, or transfusion.

Warnings

  1. Single Use Only. Do not reuse: Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single use only.
  2. Read the instructions carefully before using the device.
  3. Do not use after the expiration date has passed.
  4. Do not use if the packaging is punctured or damaged in any way.
  5. Do not use the device if the device is cracked, broken or tubing is kinked.
  6. Blood culture bottle holder must be secure before use. Do not use if holder is not connected.
  7. Do not use in a Magnetic Resonance (MR) environment.
  8. Mishandling this device may result in contaminated needlestick injury, which can cause infectious disease.
  9. Devices that become contaminated with blood are considered hazardous and must be disposed of immediately after use.
  10. The device should be discarded immediately after use in a Sharps container, following institutional policy.

CAUTION

Federal law restricts this device to sale by or on the order of a physician.

CONTRAINDICATIONS

The Monarch Safety Blood Collection Set is not intended for infusion, IV Administration, or transfusion.