BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG

    MDR report key: 20157285 · Received September 6, 2024

    Report

    Report Number
    3024508819-2024-00302
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 8, 2024
    Report Date
    November 19, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00311917025360
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED, NEEDLE BROKE OFF IN VIAL WHILE ATTEMPTING TO DRAW. STATED, SHE WAS ABLE TO REMOVE THE NEEDLE 3 SYRINGES AFFECTED STATED, DOES NOT RE-USED SYRINGES LOT: 2052384 CATALOG: 928857 DATE OF EVENT: 2024-08-08 SAMPLES: NO CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912786 SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 928857 2052384 00311917025360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown