BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU

    MDR report key: 20594770 · Received November 2, 2024

    Report

    Report Number
    3024508819-2024-00416
    Event Type
    Malfunction
    Date Received
    November 2, 2024
    Date of Event
    October 8, 2024
    Report Date
    November 2, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH IS CONSIDERED AN INITIAL AND FINAL REPORT AS THE INVESTIGATION HAS BEEN CLOSED. 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

    PHARMACY COMPLAINED ABOUT CLOGGED SYRINGE. AN OPHTHALMOLOGIST'S PRACTICE INFORMED THE PHARMACY THAT THE PLUNGER OF THE BEVACIZUMAB SYRINGE WITH THE DATE OF MANUFACTURE OF 02.10.24 COULD NOT BE PRESSED DOWN OR THE CANNULA WAS CLOGGED. THE PHARMACY PURCHASED THE BD MICRO FINE+ U100 12.7 100X0.5ML (PZN 4400156) SYRINGES WITH BATCH 0322007 (EXPIRY 11/2025) ON 11.02.2022 FROM THE WHOLESALER GOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165779 SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU Syringe, piston FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 324824 0322007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose