BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9696084 · Received February 11, 2020

    Report

    Report Number
    1920898-2020-00115
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 26, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 20 FEBRUARY 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231055. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200848496] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS COMPLAINT IS NOT MDR REPORTABLE. RECORD REVIEWED AND REPORTED ISSUE IS UPDATED TO INCORRECT PLACEMENT OF PRODUCT AND THEREFORE THIS COMPLAINT IS NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PIERCED THROUGH THE BAG. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328466 BATCH NO: 9231055. IT WAS REPORTED THAT 1 SYRINGE WITH SHIELD ATTACHED AND NEEDLE COVERED WITHIN THE SHIELD, POKED THRU THE MIDDLE OF BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PIERCED THROUGH THE BAG. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328466; BATCH NO: 9231055. IT WAS REPORTED THAT 1 SYRINGE WITH SHIELD ATTACHED AND NEEDLE COVERED WITHIN THE SHIELD, POKED THRU THE MIDDLE OF BAG.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PIERCED THROUGH THE BAG. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328466 BATCH NO: 9231055. IT WAS REPORTED THAT 1 SYRINGE WITH SHIELD ATTACHED AND NEEDLE COVERED WITHIN THE SHIELD, POKED THRU THE MIDDLE OF BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160250 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328466 9231055 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other