BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLES

    MDR report key: 16756024 · Received April 17, 2023

    Report

    Report Number
    9616656-2023-00371
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 29, 2023
    Report Date
    May 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 24-APR-2023. INVESTIGATION SUMMARY: TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 2060475, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE. DUE TO THE CONDITION THIS SAMPLE WAS RETURNED NO CLOG TEST COULD BE CARRIED OUT. A CLOG TEST WAS CARRIED OUT ON THE REMAINING SAMPLE AND NO ISSUES WERE OBSERVED. A FUNCTIONALITY TEST AS PER WAS CARRIED OUT ON BOTH RETURNED 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 SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    H3. 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 THE BD MICRO-FINE¿ PRO PEN NEEDLES WAS UNABLE TO DELIVER INSULIN. THIS IS 1 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A NEEDLE NPE BENT AND CLOG. ACCORDING TO THE USER'S REPORT, THE NEEDLE STUCK IN RUBBER STOPPER AND COULD NOT BE REMOVED. THE DRUG SOLUTION DID NOT COME OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ PRO PEN NEEDLES WAS UNABLE TO DELIVER INSULIN. THIS IS 1 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A NEEDLE NPE BENT AND CLOG. ACCORDING TO THE USER'S REPORT, THE NEEDLE STUCK IN RUBBER STOPPER AND COULD NOT BE REMOVED. THE DRUG SOLUTION DID NOT COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819611 BD MICRO-FINE¿ PRO PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2060475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown