BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11270494 · Received February 2, 2021

    Report

    Report Number
    1920898-2021-00142
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    January 11, 2021
    Report Date
    March 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/9/2021. H.6. INVESTIGATION: CUSTOMER RETURNED A SINGLE SYRINGE. THE POUCH IT WAS RETURNED IN INDICATE IT IS A 0.3ML 31 GAUGE 8MM SYRINGE FROM LOT 0083518. THE NEEDLE HUB AND SHIELD ARE MISSING ENTIRELY. THE TIP OF THE BARREL APPEARS TO HAVE BROKEN OFF. THERE ARE REMNANTS OF THE CONNECTOR AT THE DISTAL TIP OF THE BARREL. ONE SIDE BROKE VERY CLOSE TO THE FLAT MAIN SURFACE OF THE BARREL WHILE THE OTHER SIDE FEATURES A ROUGH, SLIGHTLY RAISED SECTION. THE CONNECTOR MAY HAVE BEEN BENT TO THE POINT OF FRACTURING WHILE STRUGGLING TO REMOVE THE NEEDLE SHIELD FROM THE HUB. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0083518. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200886538] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE: L2L MAINTENANCE DISPATCH # 98339 FOR RAIL JAMS GENERATED ON 30MAY2020 AT THE FFS OPERATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED NEEDLE HUB SEPARATED. VERBATIM: CONSUMER REPORTED, NEEDLE HUB SEPARATED WHEN SHE REMOVED SHIELD. 2 SYRINGES AFFECTED."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED NEEDLE HUB SEPARATED VERBATIM: CONSUMER REPORTED, NEEDLE HUB SEPARATED WHEN SHE REMOVED SHIELD. 2 SYRINGES AFFECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161186 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0083518 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1