BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 4MM PEN NEEDLE

    MDR report key: 15415428 · Received September 13, 2022

    Report

    Report Number
    9616656-2022-00982
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 16, 2022
    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

    INVESTIGATION SUMMARY: ONE OPEN AND THREE SEALED 32G X 4MM PEN NEEDLE SAMPLES AND FIVE PHOTOS WERE RETURNED FROM LOT. NO. 1132252, CAT. NO. 320136. VISUAL EXAMINATION WAS CARRIED OUT ON ALL FOUR SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON THE OPEN SAMPLE. A CLOG TEST WAS CARRIED OUT ON THE THREE 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 SAMPLE WAS RETURNED OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Additional Manufacturer Narrative · 0

    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 NANO¿ 4MM PEN NEEDLE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE USER'S REPORT, THE DRUG SOLUTION DID NOT COME OUT UPON PRIMING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 4MM PEN NEEDLE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: 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
    2622289 BD NANO¿ 4MM PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1132252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown