BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI SPIKE DISP PIN

    MDR report key: 13677715 · Received March 4, 2022

    Report

    Report Number
    MW5107909
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    March 3, 2022
    Report Date
    March 3, 2022
    Manufacturer
    B. BRAUN / B. BRAUN MELSUNGEN AG
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS CALL FROM PATIENT WHO REPORTED JUST NOW WHILE SHE WAS CREATING A NEW MIX, THE "PLUNGER PART OF THE MINI SPIKE FELL INTO THE BOTTLE OF TREPROSTINIL AND THERE IS NO WAY FOR HER TO GET IT BACK OUT" SHE V/U. SHE HAS 3 MORE VIALS OF TREPROSTINIL ON HAND SO SHE WAS ABLE TO USE ANOTHER VIAL. SHE PROVIDED THE FOLLOWING REGARDING UNUSABLE TREPROSTINIL VIAL: LOT NUMBER 884061 AND MALF MINI SPIKES: LOT NUMBERS 0061798384 AND 0061804410. SHE IS NOT SURE WHICH ONE IS THE ACTUAL LOT NUMBER FOR THE 'MALF' MINI SPIKE. UNKNOWN IF HER DOCTOR IS AWARE OF THIS EVENT. UNKNOWN IF DEFECT VIAL AND MINI SPIKE AVAILABLE FOR RETURN. NO ADVERSE EVENT FROM DEFECTIVE DEVICE REPORTED. NO OTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527277 MINI SPIKE DISP PIN SET, I.V. FLUID TRANSFER LHI B. BRAUN / B. BRAUN MELSUNGEN AG DP1800SC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female