BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 11103529 · Received January 1, 2021

    Report

    Report Number
    1920898-2020-01789
    Event Type
    Malfunction
    Date Received
    January 1, 2021
    Date of Event
    December 1, 2020
    Report Date
    January 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: 12/28/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 1/2CC SYRINGE. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0041236. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200878621] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE: ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SYRINGE. VERBATIM: CONSUMER REPORTED NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SYRINGE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 A SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SYRINGE. VERBATIM: CONSUMER REPORTED NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22 SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328466 0041236 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1