BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500

    MDR report key: 20659072 · Received November 11, 2024

    Report

    Report Number
    3024508819-2024-00438
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Report Date
    January 28, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 3RD 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. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    CONSUMER REPORTED THAT THERE IS LIQUID COMING OUT OF THE NEEDLE WHEN SHE DEPRESSES THE PLUNGER ROD. LOT #: 4037015, 4121016 CATALOG #: 328438 DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977063 SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328438 4037015 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female