BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G X 4MM BENELUX

    MDR report key: 11219905 · Received January 23, 2021

    Report

    Report Number
    9616656-2021-00060
    Event Type
    Malfunction
    Date Received
    January 23, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 1, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/1/2021. H.6. INVESTIGATION: TWELVE SEALED 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 0203705, CAT. NO.320141. A CLOG TEST WAS CARRIED OUT ON ALL TWELVE SAMPLES AS PER TP700483 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 ON THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PN 32G X 4MM BENELUX WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT IS EXPERIENCING PROBLEMS USING HIS BD MICRO-FINE ULTRA NEEDLES. ABOUT HALF OF THE NEEDLES WOULD BE CLOGGED. THE PROBLEM WOULD ONLY BE WITH THE CURRENT BOX, HE HAS USED THE SAME NEEDLES IN THE PAST WITHOUT ANY PROBLEMS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PN 32G X 4MM BENELUX WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT IS EXPERIENCING PROBLEMS USING HIS BD MICRO-FINE ULTRA NEEDLES. ABOUT HALF OF THE NEEDLES WOULD BE CLOGGED. THE PROBLEM WOULD ONLY BE WITH THE CURRENT BOX, HE HAS USED THE SAME NEEDLES IN THE PAST WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116308 PN 32G X 4MM BENELUX PEN NEEDLE FMI BECTON DICKINSON AND CO. 0203705

    Patients

    Seq Age Sex Outcome Treatment
    1