BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLE

    MDR report key: 12755674 · Received November 6, 2021

    Report

    Report Number
    9616656-2021-01376
    Event Type
    Malfunction
    Date Received
    November 6, 2021
    Date of Event
    October 6, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-11-16. INVESTIGATION SUMMARY: THREE OPEN 32G X 4MM PEN NEEDLE SAMPLES AND FOUR PHOTOS WERE RETURNED FROM AN UNKNOWN LOT. NO., CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON THE REMAINING TWO SAMPLES. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE MANUFACTURE DATE : UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE PATIENT BROUGHT THREE PEN NEEDLES TO THE HOSPITAL STATING THAT THE LENGTH OF THE NEEDLE NPE DIFFERS AMONG THESE THREE PEN NEEDLES, ONE OF WHICH WAS OBSERVED TO HAVE BROKEN OFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE PATIENT BROUGHT THREE PEN NEEDLES TO THE HOSPITAL STATING THAT THE LENGTH OF THE NEEDLE NPE DIFFERS AMONG THESE THREE PEN NEEDLES, ONE OF WHICH WAS OBSERVED TO HAVE BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653794 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown