BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA

    MDR report key: 10248503 · Received July 8, 2020

    Report

    Report Number
    1920898-2020-00810
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 17, 2020
    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# 9140639. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200826647] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA NEEDLES WERE LOOSE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENT WAS IN CONTACT TO REPORT THAT FOR AT LEAST TWO MONTHS HE HAD A PROBLEM WITH THE BD ULTRA FINE NEEDLE. THE FIRST TIME WHEN THE CAP WAS OPENED THE NEEDLE WAS LOOSE, THE OTHER TIMES THE ANGLE OF THE NEEDLE IS BENT. THERE ARE 3 NEEDLES THAT PRESENTED THE PROBLEM.

    Additional Manufacturer Narrative · 1

    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 NEEDLES WERE LOOSE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENT WAS IN CONTACT TO REPORT THAT FOR AT LEAST TWO MONTHS HE HAD A PROBLEM WITH THE BD ULTRA FINE NEEDLE. THE FIRST TIME WHEN THE CAP WAS OPENED THE NEEDLE WAS LOOSE, THE OTHER TIMES THE ANGLE OF THE NEEDLE IS BENT. THERE ARE 3 NEEDLES THAT PRESENTED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712761 SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA SYRINGE FMF BD MEDICAL - DIABETES CARE 9140639

    Patients

    Seq Age Sex Outcome Treatment
    1 Other