BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE 32G X 4MM

    MDR report key: 6949895 · Received October 13, 2017

    Report

    Report Number
    9616656-2017-00115
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 20, 2017
    Report Date
    December 1, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) SEALED 4MM, 32G PEN NEEDLES FROM LOT # 7032841. CUSTOMER STATES THAT THEY EXPERIENCED AN INFLAMED AREA/BURNED AREA AFTER USAGE AT SITE. ALL RETURNED PEN NEEDLES WERE TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD. ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. AS PER MANUFACTURING, 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. INVESTIGATION CONCLUSION: BD WAS NOT 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 ID. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ULTRA-FINE¿ PEN NEEDLE 32G X 4MM CAUSED AN INFLAMED, BURNED AREA AROUND INJECTION SITE ON FIVE OCCASIONS. SERIOUS INJURY. MEDICAL INTERVENTION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729259 BD ULTRA-FINE¿ PEN NEEDLE 32G X 4MM INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7032841

    Patients

    Seq Age Sex Outcome Treatment
    1 Other