BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA

    MDR report key: 18426445 · Received January 2, 2024

    Report

    Report Number
    1213809-2023-01506
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    December 1, 2023
    Report Date
    December 9, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTEGRA SYRINGE HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS CUSTOMER HAD A RETRACTABLE NEEDLE MALFUNCTION AND THERE WAS AN INJURY. THE ITEM NUMBER IS 305270. THE SPRING LOOSE IN THE PACKAGE AND THE UNSECURED NEEDLE IN THE BARREL FLYING OUT LIKE A DART. I REPORTED THE UNINTENTIONAL MALFUNCTION OF EQUIPMENT THAT HAS THE POTENTIAL TO AFFECT RESIDENT CARE TO NYS DOH'." NO FURTHER DETAILS PROVIDED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204249 BD INTEGRA PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other