BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31G 6MM 3B TW 100CT

    MDR report key: 9298195 · Received November 8, 2019

    Report

    Report Number
    9616656-2019-01097
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 24, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FIFTY THREE SEALED AND INTACT 31G X 6MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 7123847, CAT. NO. 320743. A CLOG TEST AS PER TP700483 WAS CARRIED OUT ON ALL FIFTY THREE SAMPLES 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE PEN NDL 31G 6MM 3B TW 100CT HAS BEEN FOUND EXPERIENCING INABILITY TO PRIME BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: HCPS REFER THAT TWO PNS FROM THE SAME BOX HAD A CLOGGED CANNULA.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT HAS BEEN REPORTED THAT THE PEN NDL 31G 6MM 3B TW 100CT HAS BEEN FOUND EXPERIENCING INABILITY TO PRIME BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: HCPS REFER THAT TWO PNS FROM THE SAME BOX HAD A CLOGGED CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088814 PEN NDL 31G 6MM 3B TW 100CT PEN NEEDLE FMI BECTON DICKINSON AND CO. 7123847

    Patients

    Seq Age Sex Outcome Treatment
    1 Other