BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLE

    MDR report key: 16989164 · Received May 23, 2023

    Report

    Report Number
    9616656-2023-00508
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 2, 2023
    Report Date
    July 27, 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: 08-JUN-2023 . H6: INVESTIGATION SUMMARY FOURTEEN SEALED AND ONE OPEN 32G X 4 MM PEN NEEDLES AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 2172163, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT THE OPEN SAMPLE AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED, DUE TO THE CONDITION THE SAMPLE WAS RETURNED NO CLOG TEST COULD BE CARRIED OUT. A CLOG TEST AND A FUNCTIONALITY TEST WAS CARRIED OUT ON THE FOURTEEN SEALED SAMPLES AND NO ISSUES WERE 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 CONFIRMED SAMPLE WAS RETURNED OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD MICRO-FINE¿ PRO PEN NEEDLE THE DRUG SOLUTION DID NOT COME OUT BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE BDJ INVESTIGATION TEAM, TRANSLATED FROM JAPANESE: THE DRUG SOLUTION DID NOT COME OUT BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD MICRO-FINE¿ PRO PEN NEEDLE THE DRUG SOLUTION DID NOT COME OUT BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE BDJ INVESTIGATION TEAM, TRANSLATED FROM JAPANESE: THE DRUG SOLUTION DID NOT COME OUT BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487295 BD MICRO-FINE¿ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown