BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINENEEDLE

    MDR report key: 12701274 · Received October 26, 2021

    Report

    Report Number
    1920898-2021-01110
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 24, 2021
    Report Date
    October 7, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : EXEC SUMMARY - SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 1053427. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. SAMPLES RETURNED - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. CAPA/SA - BASED ON THE ABOVE INVESTIGATION NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT WHEN THE NEEDLE SHIELD OF SYRINGES FROM THE BOX WERE REMOVED, THE NEEDLE HUB ASSEMBLY REMOVED WITH THE SHIELD. DATE OF EVENT : (B)(6) 2021. SAMPLE : DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598646 BD INSULIN SYRINGES WITH THE BD ULTRA FINENEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1053427

    Patients

    Seq Age Sex Outcome Treatment
    1