BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA

    MDR report key: 21000065 · Received December 23, 2024

    Report

    Report Number
    1213809-2024-00987
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    November 26, 2024
    Report Date
    February 11, 2025
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL#: 305270. BATCH NUMBER#: 4214080. IT WAS REPORTED THAT THE BD INTEGRA NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM(S): BD INTEGRA SYRINGE WITH PRECISION GUIDE NEEDLE 3MM 25G X1 INCH LOT(S): 4214080. DATE INCIDENT OCCURRED: (B)(6) 2024. WAS THE PATIENT IMPACTED? YES. IF YES, DESCRIBE: SYRINGE DEFECTIVE. PATIENT ATTEMPTED TO INJECT 0.5ML OF TESTOSTERONE BUT THE NEEDLE BLEW STRAIGHT OUT OF THE HUB OF THE SYRINGE. NEEDLE WENT COMPLETELY INTO CUSTOMER¿S HIP. RUSHED TO ER AND WILL NOW BE SEEING A SURGEON ON TUESDAY TO SCHEDULE TO HAVE IT REMOVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2621977 BD INTEGRA SYRINGE, ANTISTICK MEG BECTON DICKINSON MEDICAL SYSTEMS 4214080 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other