BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 20791947 · Received November 27, 2024

    Report

    Report Number
    3002601200-2024-00655
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 2, 2024
    Report Date
    December 3, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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. IT IS LEARNED FROM THE FOLLOW-UP INFORMATION THAT THE COMPLAINED DEFECT IS BLOOD LEAKAGE AT THE SEPTUM, AND NO DEFECTIVE SAMPLE AND PHOTO WILL BE RETURNED. 2. DHR/BHR REVIEW LOT#4052074 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MARCH 2024, AND PACKAGED AT CFS PACKAGE LINE IN MARCH 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 RELATED TESTING: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST IS PASSED, AND NO LEAKAGE IS FOUND AT THE SEPTUM. PLEASE SEE THE ATTACHED TEST REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION: NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER EXAMINATION, THE ROOT CAUSE OF THE BLOOD LEAKAGE AT THE SEPTUM CANNOT BE DETERMINED.

    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

    INFORMAITON PROVIDED BY CUSTOMER: 1)WHERE DOES THE LEAKAGE OCCURRED PARTICULARLY? ISOLATION PLUG BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED AT SEPTUM. PATIENTS IN THE INFUSION PROCESS FOUND THAT THE INDWELLING NEEDLE LEAKAGE, THE PATIENT HAS GREATER EMOTIONAL FLUCTUATIONS, TIMELY COMMUNICATION WITH THE PATIENT TO OBTAIN UNDERSTANDING AFTER RE-PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356462 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052074 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown