BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFURCATED SUBCUTANEOUS TISSUE INFUSION SET

    MDR report key: 676514 · Received December 9, 2005

    Report

    Report Number
    MW1037375
    Event Type
    Injury
    Date Received
    December 9, 2005
    Date of Event
    December 6, 2005
    Report Date
    December 7, 2005
    Manufacturer
    MARCAL MEDICAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AFTER PRIMING A 3-LEG SUBCUTANEOUS TUBING SET, THE NURSE IN THE HOME CLAMPED THE TUBING WITH THE SMALL PLASTIC CLAMP ON EACH LEG ON THE TUBING SET, PER DIRECTIONS. THE NURSE REPORTED THAT THE TUBING SEVERED AT THE 3RD OF 3 CLAMP SITES. USING A SECOND 3-LEG EXTENSION, ONE OF THE LEGS ALSO WAS SEVERED BY THE SUPPLIES, ATTACHED PLASTIC CLAMP. THE INFUSION WAS ADMINISTERED VIA THE 2 REMAINING LEGS, THE THIRD LEG REMAINED CLAMPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFURCATED SUBCUTANEOUS TISSUE INFUSION SET * FOZ MARCAL MEDICAL INC. MCTI-3606 0506026

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Disability