BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8843642 · Received July 30, 2019

    Report

    Report Number
    1920898-2019-00730
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908411035
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED EIGHT (8) LOOSE 30G X 12.7MM, 1ML BD INSULIN SYRINGES. CONSUMER REPORTED THE STOPPER IN THE BARREL IS NOT STRAIGHT. ALL EIGHT RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT ALL EIGHT SAMPLES HAD DAMAGED/DISFIGURED STOPPERS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7241945. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR DRY BARRELS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR BREAK OUT SUSTAINING. ROOT CAUSE OF THE DEFORMED STOPPER IS DUE TO SILICONE TANK RUNNING EMPTY ON MACHINE JL. SILICONE WAS ADDED TO THE TANK AND 200 CONSECUTIVE PARTS WERE RAN TO CONFIRM THE MACHINE WAS RUNNING PROPERLY PER MRB IN NOTIFICATION (B)(4). CAPA#666972 WAS OPENED ON 11NOV2019 AFTER THE DATE OF MANUFACTURE TO ADDRESS DIFFICULT AND UNABLE TO OPERATE SYRINGES, WHICH IS RELATED TO THE APPLICATION OF SILICONE IN THE BARREL.

    Description of Event or Problem · 0

    MATERIAL NO: 328411 BATCH NO: 7241945. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THE STOPPER IN THE BARREL IS NOT STRAIGHT. THIS OCCURRED ON 8 SEPARATE OCCASIONS BUT THE DATE/TIME IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THE STOPPER IN THE BARREL IS NOT STRAIGHT. OCCURENCE-8.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.

    Description of Event or Problem · 1

    MATERIAL NO: 328411, BATCH NO: 7241945. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THE STOPPER IN THE BARREL IS NOT STRAIGHT. THIS OCCURRED ON 8 SEPARATE OCCASIONS BUT THE DATE/TIME IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THE STOPPER IN THE BARREL IS NOT STRAIGHT. OCCURENCE-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634571 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7241945 00382908411035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other