BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31GA 8MM

    MDR report key: 11168324 · Received January 13, 2021

    Report

    Report Number
    1920898-2021-00043
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 16, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (2) 3/10CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 0083518. CUSTOMER STATES THAT THE SYRINGES ARE MISSING NEEDLES. BOTH RETURNED SYRINGE WERE EXAMINED AND BOTH EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9350297. 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 FOR THIS DEFECT CANNOT BE DETERMINED. CAPA1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WHEN REMOVING SHIELD OF (B)(4) BD SYRINGE 0.3ML 31GA 8MM IT WAS DISCOVERED THE NEEDLE HUB HAD SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED FOUND (B)(4) SYRINGES WITHOUT A NEEDLE ON THEM. JUST A HOLE AT TOP OF SYRINGE WHEN REMOVED SHIELD.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WHEN REMOVING SHIELD OF 6 BD SYRINGE 0.3ML 31GA 8MM IT WAS DISCOVERED THE NEEDLE HUB HAD SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED FOUND 6 SYRINGES WITHOUT A NEEDLE ON THEM. JUST A HOLE AT TOP OF SYRINGE WHEN REMOVED SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55233 BD SYRINGE 0.3ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0083518

    Patients

    Seq Age Sex Outcome Treatment
    1