BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 31G 5MM 5B XTW 105BX DE

    MDR report key: 11646138 · Received April 9, 2021

    Report

    Report Number
    9616656-2021-00369
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 11, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER 9071883. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT 9071883.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PN 31G 5MM 5B XTW 105BX DE LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "LIQUID IN PROTECTIVE CAP".

    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 WAS REPORTED THAT A PN 31G 5MM 5B XTW 105BX DE LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "LIQUID IN PROTECTIVE CAP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542361 PN 31G 5MM 5B XTW 105BX DE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9071883

    Patients

    Seq Age Sex Outcome Treatment
    1