BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLUNT FILL SYRINGE

    MDR report key: 19088598 · Received April 10, 2024

    Report

    Report Number
    MW5153721
    Event Type
    Other
    Date Received
    April 10, 2024
    Manufacturer
    BD
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CATHFLO ACTIVASE FOUND TO HAVE A PIECE OF DEBRIS FLOATING IN FLUID AFTER RECONSTITUTION. OBSERVATION OF STERILE WATER USED TO RECONSTITUTE VIAL ALSO FOUND TO HAVE 2-3 PIECES OF DEBRIS FLOATING WITHIN IT. DEPARTMENT USES BO 5 ML SYRINGE LUER-LO TIP WITH BLUNT FILL NEEDLES (18G.) TO RECONSTITUTE MEDICATIONS. THE DEBRIS DOES APPEAR TO BE DARK GREY PLASTIC PIECES FROM THE RUBBER STOPPER OF THE STERILE WATER VIAL. STERILE WATER FOR INJECTION (NOC 0409-4887-17) 10 ML VIAL LOT GL1839, EXP 9/1/2025 CATHFLO ACTIVASE (NOC 50242-041-64) LOT 3599077, EXP 10/31/2025 BLUNT FILL SYRINGE REF305062 LOT 3310907 EXP 10/31/2028.(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779543 BLUNT FILL SYRINGE SYRINGE, PISTON FMF BD 3310907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CATHFLO ACTIVASE, LOT NUMBER: 3599077, NDC: 50242-041-64.| STERILE WATER FOR INJECTION.