BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 8048527 · Received November 7, 2018

    Report

    Report Number
    9616657-2018-00051
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 19, 2018
    Report Date
    December 3, 2018
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW FOR LOT 8030726 CAT (B)(4) WAS CARRIED OUT AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THE PACKAGED LOT OR THE SUB-ASSEMBLY FOR NEEDLE CLOG 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 BRUISING/BLEEDING & LEAKAGE, & THE 4TH RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 8030726. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSULIN LEAKED FROM THE INJECTION SITE AFTER USING THE BD ULTRA FINE PEN NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 INSULIN LEAKED FROM THE INJECTION SITE AFTER USING THE BD ULTRA FINE¿ PEN NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888534 BD ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 8030726 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other