BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 11617142 · Received April 5, 2021

    Report

    Report Number
    9616656-2021-00351
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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 SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32G 4MM 100BX 1200 USA WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE CLOGGED DURING THE INJECTION AND THE PEN WILL NOT DEPRESS ALL THE WAY. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THE PEN WILL NOT DEPRESS ALL THE WAY. CONSUMER DOES NOT RE-USE. LOT #: 0142932; CATALOG #: 320122; DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 32G 4MM 100BX 1200 USA WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE CLOGGED DURING THE INJECTION AND THE PEN WILL NOT DEPRESS ALL THE WAY. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THE PEN WILL NOT DEPRESS ALL THE WAY. CONSUMER DOES NOT RE-USE. LOT #: 0142932, CATALOG #: 320122,DATE OF EVENT: UNKNOWN, SAMPLES: DISCARDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514148 PEN NDL 32G 4MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 0142932 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1