BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11691291 · Received April 19, 2021

    Report

    Report Number
    9616656-2021-00413
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32G 4MM HP 100 BOX 1200 US WAS UNABLE TO DELIVER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE CLOGGED DURING THE INJECTION. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. CONSUMER DOES NOT RE-USE.LOT #: 0203720. CATALOG #: 320550DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 WAS REPORTED THAT A PEN NDL 32G 4MM HP 100 BOX 1200 US WAS UNABLE TO DELIVER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE CLOGGED DURING THE INJECTION. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. CONSUMER DOES NOT RE-USE. LOT #:0203720. CATALOG #: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581825 PEN NDL 32G 4MM HP 100 BOX 1200 US HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0203720 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1