BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ULTRA-FINE 2 INSULIN SYRINGES

    MDR report key: 8219792 · Received January 4, 2019

    Report

    Report Number
    1920898-2018-00991
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 15, 2018
    Report Date
    January 14, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) 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# 8036922. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE EIGHT (8) NOTIFICATIONS [200747072, 200745690, 200748188, 200740711, 200746677, 200746432, 200742982, 200753240] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) 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 · 0

    IT WAS REPORTED THAT BD¿ ULTRA-FINE 2 INSULIN SYRINGES HAD THE NEEDLE PIERCED THROUGH THE SHIED AND BLISTER.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT BD¿ ULTRA-FINE 2 INSULIN SYRINGES HAD THE NEEDLE PIERCED THROUGH THE SHIED AND BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9229 BD¿ ULTRA-FINE 2 INSULIN SYRINGES INSULIN SYRINGE/NEEDLE FMF BD MEDICAL - DIABETES CARE 8036922 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other