BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE

    MDR report key: 9862421 · Received March 20, 2020

    Report

    Report Number
    1920898-2020-00287
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    March 12, 2020
    Report Date
    March 16, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282890
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR BARREL DAMAGED/CRACKED AND LEAKAGE AND THE 1ST RELATED COMPLAINT FOR PLUNGER ROD DIFFICULT TO MOVE ON LOT # 9063823. NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9063823. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200812920] NOTED FOR CRACKED BARREL. THERE WERE THREE (3) NOTIFICATIONS [200812809, 200813473, 200812377] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE HAD A CRACK CAUSING MEDICATION TO LEAK AND THE PLUNGER WAS DIFFICULT TO DRAW UP WITH A BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT ONE SYRINGE HAD A CRACK IN THE BARREL CAUSING MEDICATION TO LEAK OUT, THE CUSTOMER ADDED THAT ONCE MEDICATION IS DRAWN UP, ITS HARD TO COMPRESS OR SQUEEZE IT OUT WHEN PUSHING ON PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326538 BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328289 9063823 00382903282890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other