BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ MINI PEN NEEDLE

    MDR report key: 13667755 · Received March 4, 2022

    Report

    Report Number
    9616656-2022-00264
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 17, 2022
    Report Date
    April 28, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K110007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (33) OPEN BD AUTOSHIELD DUO PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. ALL 33 RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT 8 EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA, 1 EXHIBITED A BROKEN NPE CANNULA, AND 1 WAS MISSING A NPE INNER SAFETY SHIELD. THE SAMPLE WITH THE MISSING NPE INNER SAFETY SHIELD DID NOT EXHIBIT A DAMAGED PATIENT END (PE) OR NPE CANNULA, AND THE PE SAFETY SHIELD WAS NOT ACTIVATED. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BROKEN). THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT OR BROKEN BY THE CUSTOMER AFTER HANDLING THE PEN NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ MINI PEN NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WERE ADDITIONAL ISSUES INCLUDING BROKEN NON PATIENT END. DOA: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ MINI PEN NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : IT WAS REPORTED THAT THERE WERE ADDITIONAL ISSUES INCLUDING BROKEN NON PATIENT END. DOA : (B)(6) 2022. DATE OF EVENT : (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564344 BD ULTRA-FINE¿ MINI PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 329515 1134009 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown