BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML 30G 8MM CENTRAL EURO

    MDR report key: 19356480 · Received May 20, 2024

    Report

    Report Number
    3024508819-2024-00063
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 18, 2024
    Report Date
    August 9, 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 PROVIDED IN B4, G6, H2, H3, H11 CORRECTIONS MADE TO H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSION) 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 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. 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.

    Additional Manufacturer Narrative · 0

    THIS EVENT IS BEING REPORTED FOR THE ONE SYRINGE THAT WAS FOUND TO HAVE PROTRUDED THROUGH THE BAG AND HAD NO CAP IN PLACE AND THE NEEDLE WAS EXPOSED.

    Description of Event or Problem · 0

    DURING THE PACKING OF VOX DE/AT L221762 TODAY, THE TECHNICIANS OBSERVED THAT THE BD SYRINGES (Z113554, SUPPLIER ITEM (B)(4), SUPPLIER LOT: 2241039, PO: (B)(4) RECEIVED IN HAD MULTIPLE BAGS OPENED/RIPPED AND LOOSE SYRINGES WERE PRESENT IN THE BOXES AND OUTER BOXES (IMAGE 2 AND 4). ONE OF THESE OPENED BAGS HAD 06 OUT OF 10 SYRINGES PRESENT, AND THE OTHER 04 SYRINGES ARE UNACCOUNTED FOR. THERE WAS ALSO ONE SYRINGE FOUND WHICH HAD PROTRUDED THROUGH THE BAG AND HAD NO CAP IN PLACE AND THE NEEDLE WAS EXPOSED (IMAGE 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501289 SYRINGE 1ML 30G 8MM CENTRAL EURO SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 320935 2241039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown