BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA

    MDR report key: 20996698 · Received December 21, 2024

    Report

    Report Number
    1213809-2024-00978
    Event Type
    Injury
    Date Received
    December 21, 2024
    Date of Event
    November 23, 2024
    Report Date
    February 20, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND (B)(6) WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. TWO PHOTOS SHOW AN UNSEALED PACKAGE WITH ALL APPLICABLE PRODUCT INFORMATION, AND ONE OF THESE PHOTO SHOWS LOOSE SYRINGE IS NEXT TO THE PACKAGE, AND THE SYRINGE IS DAMAGED WITH A CUT BY THE BD LOGO, ALSO SHOWING THE CUTTER THROUGH THE STOPPER. THE NEXT PHOTO SHOWS ONE FULLY INTACT SYRINGE. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. PLEASE NOTE THAT THIS PRODUCT HAS A RETRACTABLE NEEDLE DESIGN. THE METAL CANNULA OF THE NEEDLE RETRACTS INTO THE INNER PLUNGER ROD FOR SAFETY. THE REPORTED DEFECT WAS NOT IDENTIFIED IN PHOTOS RECEIVED. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2112343. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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

    IT WAS REPORTED THAT THE BD INTEGRA NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT NEEDLE BROKE OFF VERY PAINFUL BRUISING WITH A NODULE RCC RECEIVED A COMPLAINT VIA EMAIL. HAS AN EMERGENCY BILL NEEDLE BROKE OFF VERY PAINFUL BRUISING WITH A NODULE. CONTACT NAME, NUMBER AND EMAIL: (B)(6). ITEM(S): SYRINGE NEEDLE. ADDITIONAL INFORMATION PROVIDED: THE DATE THIS HAPPENED WAS (B)(6) 2024 LOT NUMBER IS 2349876 FOR THE BD INTEGRA SYRINGE 3ML 25GX 1. THERE WAS BRUISING AND TENDERNESS THAT LASTED 5 OR 6 DAYS. HELLO I HAVE ATTACHED A PIC OF THE SYRINGE THAT THE EMERGENCY ROOM DISTRICTED LOOKING TO SEE IF THE NEEDLE WAS INSIDE. I ALSO HAVE A PICTURE OF THE PACKAGE AND THE LOT NUMBER. ALSO A PIC OF ONE OF THE NEEDLES COMPLETELY IN-TACKED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626996 BD INTEGRA SYRINGE, ANTISTICK MEG BECTON DICKINSON MEDICAL SYSTEMS 2112343 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other