BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU

    MDR report key: 20560417 · Received October 29, 2024

    Report

    Report Number
    3024508819-2024-00413
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Report Date
    January 7, 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

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTION H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & INVESTIGATION CONCLUSIONS). 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.

    Description of Event or Problem · 0

    I HAVE RECENTLY JOINED (B)(6) AS A QUALITY MANAGER AND WILL BE REACHING OUT IF WE DETECT A NON-CONFORMANCE. WE HAVE PICKED UP A FEW ISSUES WITH REGARDS TO BD U-100 326719 INSULIN SYRINGE. 1. RECEIVED EMPTY PACKS OF SYRINGES (LOT NO: 3170512 & 3269903). 2. SYRINGE PACKING DEFECTIVE: PARTIALLY OPENED OR SEAL BROKEN (LOT NO: 3269903 & 3044869). 3. NEEDLE STICKING OUT OF THE CAP LEADING TO INJURY: (LOT NO: 3325039). PLEASE REVIEW THE NCR FORM PROVIDED AND RESPOND WITH THE ROOT CAUSE AND CORRECTIVE ACTION TAKEN. ALSO, ANY RESPONSE FROM YOUR QUALITY TEAM FOR THE PREVIOUS CONCERNS WE RAISED?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320447 SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 326719 3325039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown