BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINENEEDLE

    MDR report key: 12701275 · Received October 26, 2021

    Report

    Report Number
    1920898-2021-01111
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 28, 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 · 1

    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. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. SAMPLES RETURNED - CUSTOMER RETURNED (1) LOOSE 0.5ML BD INSULIN SYRINGE FROM LOT# 1053427. THE CONSUMER REPORTED THAT 3 SYRINGES FROM THIS BOX REMOVED NEEDLE SHIELD AND NEEDLE HUB ASSEMBLY REMOVED WITH THE SHIELD. THE RETURNED SYRINGE WAS EXAMINED AND IT WAS OBSERVED THAT THE NEEDLE HUB AND SHIELD ASSEMBLY WAS DETACHED FROM THE BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THE OBSERVED ISSUE. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED REGARDING THE DISCARDED UNKNOWN DATED EVENT THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. CAPA/SA - CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THE ISSUE. 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 · 1

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE HUBS 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 ; AWAITING, DATE OF EVENT : UNKNOWN, SAMPLE : DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598643 BD INSULIN SYRINGES WITH THE BD ULTRA FINENEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1053427

    Patients

    Seq Age Sex Outcome Treatment
    1