BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA

    MDR report key: 11362122 · Received February 22, 2021

    Report

    Report Number
    1920898-2021-00198
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 15, 2021
    Report Date
    March 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0062085. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200880116] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT IN THE LAST LOT PURCHASED, ONE OF THE SYRINGES SHOWED THE FOLLOWING QUALITY DEVIATION: WHEN REMOVING THE ORANGE PROTECTIVE CAP, THE NEEDLE (ALONG WITH THE PLASTIC PART) DETACHED ITSELF FROM THE BODY OF THE SYRINGE, GETTING STUCK IN THE ORANGE CAP.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). 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 SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT IN THE LAST LOT PURCHASED, ONE OF THE SYRINGES SHOWED THE FOLLOWING QUALITY DEVIATION: WHEN REMOVING THE ORANGE PROTECTIVE CAP, THE NEEDLE (ALONG WITH THE PLASTIC PART) DETACHED ITSELF FROM THE BODY OF THE SYRINGE, GETTING STUCK IN THE ORANGE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257126 SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA SYRINGE FMF BD MEDICAL - DIABETES CARE 0062085

    Patients

    Seq Age Sex Outcome Treatment
    1