BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 20334505 · Received September 30, 2024

    Report

    Report Number
    3002601200-2024-00472
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    July 4, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830572
    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#4052076. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024 AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 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 SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR FUNCTIONAL TESTING: 45PSI LEAKAGE TEST. THE TEST IS PASSED, AND NO LEAKAGE IS FOUND. PLEASE REFER TO THE ATTACHMENT FOR THE TEST REPORT. 4. THIS PRODUCT (SKU 383057) HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE THE PRODUCT OF THIS SKU HAS NOT BEEN DECLARED FOR HIGH PRESSURE INJECTION, AND NO DEFECTIVE SAMPLE HAS BEEN RECEIVED, THE ROOT CAUSE OF LEAKAGE CANNOT BE CONFIRMED TO BE RELATED TO PRODUCT QUALITY.

    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 INFORMAITON PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 20GAX1.16IN PRN SLM NPVC LEAKED WITH POWER INJECTOR ON (B)(6) 2024 THE PATIENT PERFORMED CT ENHANCEMENT + 3D RECONSTRUCTION OF THE PULMONARY ARTERY, THE NURSE USED A 20G INDWELLING NEEDLE WITH THE OUTER PACKAGE INTACT, AFTER SUCCESSFUL PUNCTURE AND USE NS 5ML TO FLUSH THE TUBE, THERE IS NO SWELLING AT THE PUNCTURE AND NO LEAKAGE OF FLUID FROM THE INDWELLING NEEDLE, THE VENOUS PATHWAY IS SMOOTH IN THE PROCESS OF THE TRIAL INJECTION, THE PATIENT COMPLAINED OF NO SPECIAL DISCOMFORT, IN THE HIGH-PRESSURE INJECTION OF IOHEXADOL INJECTION, THE IMAGE DOES NOT ENHANCE THE DRUG DISPLAY, TO VIEW THE PATIENT THERE IS A LEAKAGE OF FLUID AROUND THE INDWELLING NEEDLE. IMMEDIATELY REMOVE THE INDWELLING NEEDLE, REPLACE THE INDWELLING NEEDLE AFTER THE PUNCTURE OF THE VENOUS ACCESS IS SMOOTH, RE-DRAW IODIXANOL, TO 3ML/S INTRAVENOUS HYPERBARIC INJECTION OF IODIXANOL 70ML, THE PATIENT COMPLAINED OF NO DISCOMFORT, THE END OF THE EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610636 BD INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052076 00382903830572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown