BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7070460 · Received November 30, 2017

    Report

    Report Number
    1920898-2017-00354
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 7, 2017
    Report Date
    January 9, 2018
    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
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    BD RECEIVED (13) 1/2CC, 12.7MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 7030518. CUSTOMER STATES THAT THE SYRINGES ARE DEPRESSED AT 0 AND THE HUB AND NEEDLE WILL BE OFF WHEN THE SHIELD WAS TAKEN OFF. ALL RETURNED SYRINGES WERE EXAMINED AND NO DEFECTS WERE OBSERVED ON ANY PART OF THE SYRINGES. ALSO, ALL SYRINGES WERE TESTED AND NO HUB-NEEDLE ASSEMBLY SEPARATED FROM THE BARREL WHEN REMOVING THE SHIELD. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7030518. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200683338] NOTED THAT WAS RELATED TO CRACKED HUBS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSUMER RECEIVED A PACKAGE OF BD INSULIN SYRINGE(S) WITH BD ULTRA-FINE¿ NEEDLE(S) THAT HAD DEFECTIVE PLUNGERS. THIS WAS NOTICED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852676 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7030518 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other