BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20495897 · Received October 21, 2024

    Report

    Report Number
    3002601200-2024-00539
    Event Type
    Malfunction
    Date Received
    October 21, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 23, 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. 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 (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 RELEVANT FUNCTIONAL TESTS: 800MM SIMULATED CLINICAL LEAKAGE TEST AND 45PSI LEAKAGE TEST. THE TESTS ARE PASSED, AND NO LEAKAGE IS FOUND AT THE SAMPLE. PLEASE SEE THE ATTACHED 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. BECAUSE THE SPECIFIC BLEEDING SITE AND ABNORMAL STATE OF THE INDWELLING NEEDLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE BLEEDING CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED (B)(6) 2024 AFTER AN INDWELLING NEEDLE IS PLACED IN A PATIENT'S VEIN, THE PATIENT'S VENOUS BLOOD SPILLS OUT OF THE END OF THE INDWELLING NEEDLE, PROMPTLY REMOVING THE DEFECTIVE NEEDLE AND APPLYING PRESSURE TO STOP THE BLEEDING, REASSURING THE PATIENT AND EXPLAINING WHY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011879 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTERVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052079 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown