BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16574858 · Received March 20, 2023

    Report

    Report Number
    9616656-2023-00249
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    March 1, 2023
    Report Date
    April 27, 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: 13-SEP-2023 H6: INVESTIGATION SUMMARY ONE OPEN 32G X 4MM PEN NEEDLE CARTON AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 2060475, CAT. NO. 320559 CONTAINING THE FOLLOWING PEN NEEDLE SAMPLES: FIVE SEALED 32G X 4MM PEN NEEDLE POLYBAGS AND FOUR LOOSE SEALED 32G X 4MM PEN NEEDLES FROM LOT. NO. 2060475. A CLOG TEST AS PER Q-SOP-183-DL WAS CARRIED OUT ON THIRTY SEALED SAMPLES RETURNED FROM LOT. NO. 2060475 AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL CONFIRMED SAMPLES WERE RETURNED OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE. H3 OTHER TEXT : SEE H10

    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 (70 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THIS OCCURRED 10 TIMES. 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 CUSTOMER'S REPORT, THE DRUG SOLUTION DID NOT COME OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THIS OCCURRED 10 TIMES. 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 CUSTOMER'S REPORT, THE DRUG SOLUTION DID NOT COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775577 BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2060475 00382903205592

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown