BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLES

    MDR report key: 16980646 · Received May 22, 2023

    Report

    Report Number
    9616656-2023-00505
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    April 28, 2023
    Report Date
    June 8, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 25-MAY-2023. H6: INVESTIGATION SUMMARY ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND TWO PHOTOS WERE RETURNED FROM LOT. NO. 2172163, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND A BROKEN NON PATIENT END OF CANNULA 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 SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD MICRO-FINE¿ PRO PEN NEEDLES WAS BROKEN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORTED THAT THE NEEDLE NPE WAS BROKEN DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD MICRO-FINE¿ PRO PEN NEEDLES WAS BROKEN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORTED THAT THE NEEDLE NPE WAS BROKEN DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780501 BD MICRO-FINE¿ PRO PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2172163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown