BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB

    MDR report key: 12236156 · Received July 28, 2021

    Report

    Report Number
    1213809-2021-00518
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 28, 2021
    Report Date
    August 3, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052722
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D10: RETURNED TO MANUFACTURER ON: 2021-07-20. H6: INVESTIGATION SUMMARY FOUR 3ML INTEGRA SYRINGES (P/N 305272) IN SEALED BLISTERPAKS FROM BATCH #0002379 WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED AND FUNCTIONALLY TESTED. THERE WERE NO VISIBLE DEFECTS ON THE SYRINGE, OR DAMAGE TO THE COLLAR OR TIP AREA THAT WOULD INHIBIT A CONNECTION. ADDITIONALLY, ALL READINGS FOR PLUNGER ROD COLLAPSE AND HUB CUT WERE WITHIN SPECIFICATION AFTER TESTING. THE INSTRUCTIONS FOR USE STATE: "ATTACH THE BD INTEGRA RETRACTING PRECISIONGLIDE NEEDLE FIRMLY ONTO THE BD INTEGRA SYRINGE WITH A PUSH AND A CLOCKWISE TWIST" PRIOR TO USE. IT IS UNCLEAR IF THIS WAS DONE PRIOR TO USAGE. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITIONS WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. 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

    IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB LEAKED AND HAD THE NEEDLE RETRACT PREMATURELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT WHILE ADMINISTERING MEDICATION TO PATIENT, NEEDLE RETRACTED PRIOR TO FINISHING THE INJECTION. IT WAS ALSO REPORTED THAT WHILE GIVING ANOTHER INJECTION, MEDICINE LEAKED OUT OF WHERE THE SYRINGE AND NEEDLE ATTACH.".

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB LEAKED AND HAD THE NEEDLE RETRACT PREMATURELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHILE ADMINISTERING MEDICATION TO PATIENT, NEEDLE RETRACTED PRIOR TO FINISHING THE INJECTION. IT WAS ALSO REPORTED THAT WHILE GIVING ANOTHER INJECTION, MEDICINE LEAKED OUT OF WHERE THE SYRINGE AND NEEDLE ATTACH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139848 SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305272 0002379 30382903052722

    Patients

    Seq Age Sex Outcome Treatment
    1