BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT)

    MDR report key: 17101421 · Received June 9, 2023

    Report

    Report Number
    9616656-2023-00571
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 10, 2023
    Report Date
    June 29, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205592
    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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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: 08-JUN-2023 . H6: INVESTIGATION SUMMARY ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 2172163, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS 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 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 DETERMINE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT) THE NEEDLE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT THE NEEDLE CLOG. ACCORDING TO THE USER'S REPORT, THE DRUG SOLUTION DID NOT COME OUT. THE LOT#2172163C WAS NOT FOUND BUT LOT#2172163, WHICH WAS ADDED IN MATERIALS INFO.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT) THE NEEDLE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT THE NEEDLE CLOG. ACCORDING TO THE USER'S REPORT, THE DRUG SOLUTION DID NOT COME OUT. THE LOT#2172163C WAS NOT FOUND BUT LOT#2172163, WHICH WAS ADDED IN MATERIALS INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453084 BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2172163 00382903205592

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown