BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11014237 · Received December 15, 2020

    Report

    Report Number
    1920898-2020-01711
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 19, 2020
    Report Date
    March 9, 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

    H.6. INVESTIGATION: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. 2 PHOTO OF (1) LOOSE 0.3ML BD INSULIN SYRINGE WAS PROVIDED. THE CUSTOMER REPORTED THAT THE NEEDLE WITH THE SHIELD WAS SEPARATED FROM THE BARREL. THE RETURNED PHOTOS WERE REVIEWED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE BARREL; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. DUE TO BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#: 1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP HUB WAS SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP HUB WAS SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474712 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1