BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDLE¿ ULTRA-FINE III

    MDR report key: 8244952 · Received January 14, 2019

    Report

    Report Number
    9616656-2018-00391
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 25, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) OPEN 8MM, 31G PEN NEEDLES WITHOUT THE TEAR DROP LABEL. 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 RANKING IS S1. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE MISSING ON LOT # 8143539. INVESTIGATION CONCLUSION: ALL RETURNED PEN NEEDLES WERE EXAMINED AND ALL EXHIBITED A BROKEN NON PATIENT END OF THE CANNULA. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. RATIONALE: 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEN NEEDLE¿ ULTRA-FINE III WAS MISSING AT PATIENT END OF PEN NEEDLE HUB. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PEN NEEDLE¿ ULTRA-FINE III WAS MISSING AT PATIENT END OF PEN NEEDLE HUB. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37150 BD PEN NEEDLE¿ ULTRA-FINE III INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 8143539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other