BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 11670770 · Received April 15, 2021

    Report

    Report Number
    1920898-2021-00405
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 28, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: CUSTOMER RETURNED IMAGES OF TWO SYRINGES WITH A POUCH LABELED FOR 0.3ML, 29 GAUGE, 12.7MM SYRINGES FROM LOT 0160988. THE SYRINGES FEATURED THEIR NEEDLE SHIELD AND HUB SEPARATED FROM THE BARREL. THE HUBS HAVE BECOME LODGED INSIDE THE SHIELDS. THERE IS NO DAMAGE TO EITHER THE CONNECTORS AT THE DISTAL TIP OF THE BARRELS OR THEIR RESPECTIVE NEEDLE HUBS. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0160988. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CAPA #1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED ABOUT NEEDLE/SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE SHIELD."

    Additional Manufacturer Narrative · 1

    "A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED ABOUT NEEDLE/SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE SHIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568392 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0160988

    Patients

    Seq Age Sex Outcome Treatment
    1