BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE

    MDR report key: 16261168 · Received January 28, 2023

    Report

    Report Number
    1213809-2023-00044
    Event Type
    Malfunction
    Date Received
    January 28, 2023
    Date of Event
    January 5, 2023
    Report Date
    February 9, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 07-FEB-2023. H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A CRACK WAS OBSERVED FROM THE BARREL FLANGE TO 2ML GRADUATION LINE. POTENTIAL ROOT CAUSE FOR THE BARREL CRACKED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1201874. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHILE USING BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE THERE WAS A CRACK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY WENT TO DRAW UP THE VIAL AND THEY NOTICED A CRACK IN THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE THERE WAS A CRACK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY WENT TO DRAW UP THE VIAL AND THEY NOTICED A CRACK IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846296 BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 305270 1201874 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown