BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PEN NEEDLES 31G X 5MM (70 COUNT)

    MDR report key: 16774058 · Received April 20, 2023

    Report

    Report Number
    9616656-2023-00380
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 31, 2023
    Report Date
    May 11, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMF
    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: ONE OPEN 31G X 5MM PEN NEEDLE SAMPLE AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 2012551, CAT. NO. 320129. A CLOG TEST WAS CARRIED OUT ON THE RETURNED SAMPLE 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. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLE THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    H.3. 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¿+ PEN NEEDLES 31G X 5MM (70 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THIS OCCURRED TWICE. 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 UPON PRIMING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE¿+ PEN NEEDLES 31G X 5MM (70 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THIS OCCURRED TWICE. 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 UPON PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590872 BD MICRO-FINE¿+ PEN NEEDLES 31G X 5MM (70 COUNT) PISTON SYRINGE FMF BECTON DICKINSON AND CO. 2012551

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown