BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLES

    MDR report key: 16016084 · Received December 20, 2022

    Report

    Report Number
    9616656-2022-01381
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    December 1, 2022
    Report Date
    January 18, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 TWENTY ONE OPEN 32G X 4 MM PEN NEEDLE SAMPLES AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 2060475, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON ALL TWENTY ONE SAMPLES AND PHOTOS AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON THIRTEEN SAMPLES AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE REMAINING EIGHT SAMPLES. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TEST COULD BE CARRIED OUT. 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. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 BD MICRO-FINE¿ PRO PEN NEEDLES CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN CHECKING THE PRODUCTS, THE HOSPITAL STAFF FOUND THAT THE NEEDLE NPE WAS BENT IN SOME PRODUCTS AND BROKEN IN THE OTHER PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 BD MICRO-FINE¿ PRO PEN NEEDLES CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN CHECKING THE PRODUCTS, THE HOSPITAL STAFF FOUND THAT THE NEEDLE NPE WAS BENT IN SOME PRODUCTS AND BROKEN IN THE OTHER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2700112 BD MICRO-FINE¿ PRO PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2060475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown