BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 8MM 10BAG 500 L AMR

    MDR report key: 19827728 · Received July 25, 2024

    Report

    Report Number
    3024508819-2024-00214
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    July 3, 2024
    Report Date
    October 17, 2024
    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

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION, AND INVESTIGATION CONCLUSIONS) 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

    A CUSTOMER GOT IN TOUCH TO SAY THAT HE PICKS UP SYRINGES FOR DIABETES TREATMENT AT THE UBS IN INTERLAGOS. INTERLAGOS FOR MANY YEARS, HE COMMENTED THAT HE TAKES A CLOSED BOX WITH 10 PACKS OF SYRINGES AND AT THE TIME OF USE HE HAD TWO OPEN PACKS OF SYRINGES. AND AT THE TIME OF USE HE HAD TWO OPEN PACKS OF SYRINGES AND DOESN'T KNOW WHICH BATCH THE SYRINGE IS FROM. THE SAME BATCH, ONLY THE LETTER 1207471 C FAB 09-2021 VAL 08-2026 1207471 D FAB 09-2021 VAL 08-2026 AND IN ONE OF THE SYRINGES IN USE HE NOTICED THAT IT WAS AS IF IT HAD BEEN BURNT NEAR THE EMBOLUS WITH MELTED, AND BETWEEN THE BLACK RUBBER AND THE NEEDLE THERE IS A BLACK LIQUID THAT LOOKS LIKE A FUNGUS. SAID THE CUSTOMER, AND HE REPORTED THAT HE HAD EVEN INSERTED THE NEEDLE INTO THE INSULIN BOTTLE AND CONTAMINATED THE THE INSULIN WITH THE LIQUID THAT WAS IN THE SYRINGE, MAKING IT IMPOSSIBLE TO USE. MATERIAL: SYRINGE BD ULTRA-FINE 8MM 1OO UI. MATERIAL#:328328. LOT#: 1207471 C FAB 09-2021 VAL 08-2026 1207471 D FAB 09-2021 VAL 08-2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353465 SYRINGE 1.0ML 30GA 8MM 10BAG 500 L AMR SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328328 1207471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female