BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9526310 · Received December 27, 2019

    Report

    Report Number
    1920898-2019-01475
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 9, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908440035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 13 JANUARY 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# 9112704. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE THREE (3) NOTIFICATIONS [200821671, 200821662, 200821922] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328440 BATCH NO. 9112704 IT WAS REPORTED THAT NEEDLE HUB SEPARATED INTO NEEDLE SHIELD ON 2 SYRINGES. VERBATIM: CONSUMER REPORTED NEEDLE HUB SEPARATED AND STAYED INSIDE THE SHIELD, TWO SYRINGES INVOLVED. CONSUMER DOES NOT RE-USE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328440 BATCH NO. 9112704 IT WAS REPORTED THAT NEEDLE HUB SEPARATED INTO NEEDLE SHIELD ON 2 SYRINGES. VERBATIM: CONSUMER REPORTED NEEDLE HUB SEPARATED AND STAYED INSIDE THE SHIELD, TWO SYRINGES INVOLVED. CONSUMER DOES NOT RE-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322793 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328440 9112704 00382908440035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other