BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 22GAX1.00IN PRN SLM NPVC

    MDR report key: 20956089 · Received December 17, 2024

    Report

    Report Number
    3002601200-2024-00747
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 31, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW LOT#4012416. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN JANUARY 2024, AND PACKAGED AT CFS PACKAGE LINE IN JANUARY 2024. WORK ORDER QUANTITY WAS (B)(4) EA. 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTS: 800MM SIMULATED CLINICAL LEAKAGE TEST AND 45PSI LEAKAGE TEST. THE TEST RESULTS SHOW THAT NO LEAKAGE IS FOUND. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORTS. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): SINCE NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND NO DEFECTIVE SAMPLE IS RECEIVED, THE ROOT CAUSE OF THE END OF THE INDWELLING NEEDLE LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Additional Manufacturer Narrative · 0

    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

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 22GAX1.00IN PRN SLM NPVC LEAKED. AT 9:30 A.M. ON (B)(6) 2024, THE NURSE GAVE A SURGICAL PATIENT A LEFT-HANDED INDWELLING NEEDLE INFUSION TREATMENT, AFTER SUCCESSFUL PLACEMENT OF THE TUBE FOUND THAT THE END OF THE INDWELLING NEEDLE LEAKAGE CAN NOT CONTINUE TO BE USED, IMMEDIATELY PULLED OUT AND REPLACE THE INDWELLING NEEDLE TO THE RIGHT HAND TO PUNCTURE AGAIN, THE WHOLE PROCESS OF THE PATIENT IS AWAKE, AFTER A PATIENT'S PATIENCE AND EXPLANATION SO THAT THE PATIENT ACCEPTS AND UNDERSTANDS, AND THEN RETAINED THE PROBLEMATIC DEVICE AND REPORTED THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485373 BD INTIMA-II 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4012416

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown