BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM

    MDR report key: 16114748 · Received January 6, 2023

    Report

    Report Number
    9616656-2022-01454
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 24, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 10-JAN-2023 . H6: INVESTIGATION SUMMARY : FOUR OPEN AND ONE HUNDRED AND EIGHT SEALED 32G X 4MM PEN NEEDLE SAMPLES AND SIX PHOTOS WERE RETURNED FROM LOT. NO. 2040130, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE FOUR OPEN SAMPLES AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON TWO SAMPLES, DUE TO THE CONDITION THESE SAMPLES WERE RETURNED NO CLOG TEST COULD BE CARRIED OUT. A CLOG TEST WAS CARRIED OUT ON THE TWO REMAINING OPEN SAMPLES ALONG WITH TWENTY EIGHT SEALED SAMPLES AS PER Q-SOP-183-DL 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 SAMPLES WERE RETURNED OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM THE MEDICATION COULD NOT BE DELIVERED. 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 NEEDLE CLOG. ACCORDING TO THE USER'S REPORT, THE DRUG SOLUTION DID NOT COME OUT UPON PRIMING. WHEN ANOTHER PEN NEEDLE FROM THE SAME LOT, THE SAME ISSUE OCCURRED. WHEN ANOTHER NEEDLE FROM A DIFFERENT LOT, THE DRUG SOLUTION CAME OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM THE MEDICATION COULD NOT BE DELIVERED. 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 NEEDLE CLOG. ACCORDING TO THE USER'S REPORT, THE DRUG SOLUTION DID NOT COME OUT UPON PRIMING. WHEN ANOTHER PEN NEEDLE FROM THE SAME LOT, THE SAME ISSUE OCCURRED. WHEN ANOTHER NEEDLE FROM A DIFFERENT LOT, THE DRUG SOLUTION CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392176 BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2040130 00382903205592

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown