BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SHORT PEN NEEDLE

    MDR report key: 13999023 · Received April 4, 2022

    Report

    Report Number
    9616656-2022-00379
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 16, 2022
    Report Date
    April 25, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403801518
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 28-MAR-2022. H.6. INVESTIGATION: CUSTOMER RETURNED 4 UNUSED 8MM, 32 GAUGE PEN NEEDLES FROM LOT 1202175. NO DEFECTS WERE OBSERVED ON THE UNUSED PEN NEEDLES. EACH PEN NEEDLE WAS TESTED ON A SKIN ANALOG. NONE OF THE PEN NEEDLE CANNULAS WERE BENT OR BROKEN AFTER USE. THE OUTER DIAMETERS OF THESE NEEDLES WERE MEASURED. ALL OF THE NEEDLES WERE MEASURED AT 0.0104 IN., WHICH IS WITHIN ACCEPTABLE OUTER DIAMETERS FOR 31 GAUGE NEEDLES (0.0100 IN TO 0.0105 IN). THE INTEGRITY OF EACH NEEDLE POINT WAS INSPECTED AND NO DEFECTS WERE FOUND. NO DEBRIS WAS FOUND AT THE TIP OF ANY OF THE NEEDLES. LASTLY, FLOUR WAS APPLIED TO THE NEEDLES¿ CANNULAS TO ENSURE THAT LUBRICANT WAS PRESENT. SUFFICIENT LUBRICANT WAS FOUND ON ALL SAMPLES. NO DAMAGE TO THE NEEDLES OF ANY KIND WAS OBSERVED AND ALL FUNCTIONED AS INTENDED. THE NEEDLES WERE WITHIN SPECIFICATIONS AND DID NOT FEATURE ANY DULLNESS OR BURRS THAT COULD RESULT IN PATIENT HARM. 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. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLES BREAKING. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED BD ULTRA-FINE¿ SHORT PEN NEEDLE HAD THE CANNULA BREAK OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE REPORTED HER HUSBAND HAS BROKEN A COUPLE OF NEEDLES WHEN TAKING INJECTION".

    Description of Event or Problem · 0

    IT WAS REPORTED BD ULTRA-FINE¿ SHORT PEN NEEDLE HAD THE CANNULA BREAK OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE REPORTED HER HUSBAND HAS BROKEN A COUPLE OF NEEDLES WHEN TAKING INJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166732 BD ULTRA-FINE¿ SHORT PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8015 1202175 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown