BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA

    MDR report key: 20430222 · Received October 11, 2024

    Report

    Report Number
    3024508819-2024-00389
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 2, 2024
    Report Date
    January 3, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. 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. EMBECTA WAS UNABLE 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. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE SYRINGES ARE NOT PULLING THE MEDICINE OUT OF THE BOTTLE. CUSTOMER HAS 2 OPEN BAGS WITH PROBLEMS, ONE OF THEM WAS OPENED IN MAY OF THIS YEAR SHE REPORTED THE INCIDENT, AND WE OPENED CASE (B)(4). CUSTOMER INFORMS THAT THE ISSUE OCCURS DURING USE WHEN SHE WAS GOING TO INJECT HER DAUGHTER. THE BAGS HAVE THE SAME SKU 324918 BUT BATCH NUMBERS ARE DIFFERENT: 2087972 Z AND 2192436 A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294380 SYRINGE 1ML 31GA 6MM 10 BAG 500 SLA SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 324918 2192436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female