BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM60 F1200 STERILE TUBING SET

    MDR report key: 5658709 · Received May 13, 2016

    Report

    Report Number
    MW5062277
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Date of Event
    April 25, 2016
    Report Date
    April 28, 2016
    Manufacturer
    REPRO-MED SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ON 14:28, (B)(6) 2016. PATIENT CALLED TO REPORT "PRODUCT PROBLEM" ATTRIBUTED TO THE FREEDOM 1200 TUBING (LOT 1.212/13; EXPIRATION 2018-08) SHIPPED TO THE PATIENT (B)(6) AND DELIVERED VIA FEDEX (B)(6) 2016. ((B)(6)) THE PATIENT PREPARED HIS 50ML DOSE OF HIZENTRA AS USUAL, DRAWING THE MEDICATION INTO A 60ML SYRINGE, ATTACHING THE FREEDOM TUBING, SUB-Q QUADFURCATED SET, AND PLACING THE SYRINGE INTO THE FREEDOM 60 SYRINGE INFUSION PUMP. ACCORDING TO THE PATIENT, "ABOUT 1 HOUR INTO THE PROCESS, MEDICATION WAS SQUIRTING OUT AT THE TOP OF THE FREEDOM TUBE." THE PATIENT REPLACED THE TUBING (HE HAD EXTRA TUBING) TO COMPLETE HIS INFUSION, BUT ESTIMATES THAT HE LOST ABOUT 20% (10ML) OF HIS INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307811 FREEDOM60 F1200 STERILE TUBING SET INFUSION SET FRN REPRO-MED SYSTEMS, INC. F1200 1.212/13

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR