BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ PRO PEN NEEDLE

    MDR report key: 16019906 · Received December 20, 2022

    Report

    Report Number
    9616656-2022-01394
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    December 2, 2022
    Report Date
    January 20, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 25-JAN-2023. H6: INVESTIGATION SUMMARY. ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 2110719, CAT. NO. 320562. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED. NO FOREIGN MATTER WAS OBSERVED. 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 THE SAMPLE RETURNED WAS OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLASTIC FOREIGN MATTER WAS FOUND ON 3 BD MICRO-FINE ULTRA¿ PRO PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THERE IS A PLASTIC ON THE NEEDLE THAT YOU PUT IN THE PEN".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLASTIC FOREIGN MATTER WAS FOUND ON 3 BD MICRO-FINE ULTRA¿ PRO PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THERE IS A PLASTIC ON THE NEEDLE THAT YOU PUT IN THE PEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463373 BD MICRO-FINE ULTRA¿ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2110719

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown