BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 8176564 · Received December 18, 2018

    Report

    Report Number
    9616656-2018-00349
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 21, 2018
    Report Date
    December 26, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903204786
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) OPEN 4MM, 32G PEN NEEDLE WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT THE NEEDLE WAS CROOKED AND THE INSULIN DID NOT APPLY. THE RETURNED PEN NEEDLE WAS EXAMINED AND EXHIBITED A BENT NON PATIENT END OF THE CANNULA WHICH COULD PREVENT INSULIN FROM FLOWING THROUGH THE CANNULA CORRECTLY. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE BENT & DIFFICULT/UNABLE TO OPERATE ON LOT # 8030936. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. 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¿ INSULIN PEN NEEDLES WERE BENT AND THE CUSTOMER COULD NOT DELIVER THE INSULIN.

    Additional Manufacturer Narrative · 1

    (B)(6). 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¿ INSULIN PEN NEEDLES WERE BENT AND THE CUSTOMER COULD NOT DELIVER THE INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016920 BD ULTRA FINE¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 8030936 00382903204786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other