BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 20789126 · Received November 26, 2024

    Report

    Report Number
    3002601200-2024-00652
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 25, 2024
    Report Date
    December 9, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW LOT#4052079 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS 198,000 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. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTING: 800MM SIMULATED CLINICAL LEAKAGE TEST AND 45PSI LEAKAGE TEST. THE TESTS ARE PASSED, NO LEAKAGE IS FOUND ON THE SAMPLE. 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): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS THE DEFECT STATES AT THE PADDLE HUB OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE LEAKAGE THERE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED AT CATHETER JUNCTION MATERNAL AMNIOTIC FLUID AFI 62, 2024-10-21 11:30 FOLLOWED THE DOCTOR'S INSTRUCTIONS TO GIVE 0.9% SODIUM CHLORIDE INJECTION 500 ML + VITAMIN C1G INTRAVENOUS DRIP, USING A CLOSED VENOUS INDWELLING NEEDLE FOR PUNCTURE, AFTER PUNCTURE THERE IS A REFLUX OF BLOOD FROM THE HANDLE OF THE NEEDLE, AND THERE IS A LIQUID OUTFLOW AT THE HANDLE OF THE NEEDLE AFTER OPENING THE INFUSION REGULATOR, IMMEDIATELY STOP THE INTRAVENOUS INFUSION, REPLACE THE VENOUS CLOSED INDWELLING NEEDLE AND THEN RE-PUNCTURE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368725 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052079 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown