BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-VENTED DISPENSING PIN WITH LUER LOCK SAFSITE VALVE

    MDR report key: 13076910 · Received December 22, 2021

    Report

    Report Number
    MW5106242
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    December 21, 2021
    Report Date
    December 21, 2021
    Manufacturer
    B.BRAUN MEDICAL INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NON-VENTED DISPENSING PIN WITH LUER LOCK SAFSITE VALVE USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): REF (B)(4), PRODUCT CODE DP3500L, GTIN (B)(4), LOT 0061802770, MANUFACTURER B.BRAUN MEDICAL INC. THE DISPENSING PIN WAS USED TO SPIKE A LITER OF STERILE WATER FOR DRUG DILUENT USE IN PREPARING REMDESIVIR DOSES FOR COVID-19 POSITIVE HOSPITALIZED PATIENTS. THE DISPENSING PIN WAS FOUND TO LEAK AFTER THE MEDICATION WAS COMPOUNDED AND DELIVERED TO UNIT FOR PATIENT ADMINISTRATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964573 NON-VENTED DISPENSING PIN WITH LUER LOCK SAFSITE VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA B.BRAUN MEDICAL INC PRODUCT CODE DP3500L 0061802770

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male REMDESIVIR 100MG VIAL: (B)(6) 2021| STERILE WATER FOR INJECTION USP 1 LITER, BAXTER