BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI SPIKE DISP PIN

    MDR report key: 11982623 · Received June 10, 2021

    Report

    Report Number
    MW5101818
    Event Type
    Injury
    Date Received
    June 10, 2021
    Report Date
    June 8, 2021
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    LHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM PATIENT'S DAUGHTER WHO REPORTED THAT THE REMODULIN VIALS HAVE BEEN LEAKING WHEN THEY USE THE MINI SPIKE DISP PIN TO DRAW OUT THE MEDICATION. SHE SAID THAT THEY HAVE BEEN SENT THESE SPIKES FOR THE PAST FEW SHIPMENTS AND THEY ALWAYS HAVE PROBLEMS WITH THEM. UNKNOWN IF THE DOCTOR IS AWARE. NO OTHER INFORMATION PROVIDED THERE IS NO LOT NUMBER AVAILABLE FOR THE PREVIOUS SHIPMENT OF MINI SPIKE SENT TO THE PATIENT. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874962 MINI SPIKE DISP PIN SET, I.V. FLUID TRANSFER LHI B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1