BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

    MDR report key: 12969233 · Received December 9, 2021

    Report

    Report Number
    9614033-2021-00144
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 10, 2021
    Report Date
    July 20, 2022
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY PHOTOS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, DAMAGED LUER LOCK IS OBSERVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL HAD A BENT TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " I NOTICE A MALFORMATION IN THE SYRINGE ADAPTER ".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL HAD A BENT TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " I NOTICE A MALFORMATION IN THE SYRINGE ADAPTER ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865406 BD SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON DE MEXICO 1011657

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown