BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 20305813 · Received September 25, 2024

    Report

    Report Number
    3002601200-2024-00462
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 29, 2024
    Report Date
    October 8, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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 PHOTOGRAPH HAVE BEEN RECEIVED, AND BASED ON THE LIMITED INFORMATION, IT IS DIFFICULT TO DETERMINE THE SPECIFIC LEAKAGE SITE OF THE INDWELLING NEEDLE. 2. DHR/BHR REVIEW LOT#4081466 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2024, AND PACKAGED AT CFS PACKAGE LINE IN MAY 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. 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. BECAUSE THE SPECIFIC LEAKAGE SITE AND ABNORMAL STATE OF THE DEFECTIVE SAMPLE CANNOT BE IDENTIFIED, SO THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED. THE CHILD WAS ADMITTED TO THE HOSPITAL FOR WHEEZING BRONCHITIS, AND WAS GIVEN INTRAVENOUS INFUSION THERAPY AFTER ADMISSION, AND AFTER PUNCTURE, IT WAS FOUND THAT THERE WAS BLOOD LEAKAGE AT THE TAIL OF THE INDWELLING NEEDLE AFTER PUNCTURE. THE INDWELLING NEEDLE WAS REMOVED, AND DUE TO THE YOUNG AGE OF THE CHILD, AFTER COMMUNICATING WITH THE CHILD'S FAMILY TO EXPLAIN AND REASSURE, THE INDWELLING NEEDLE WAS REPLACED WITH A NEW ONE AND RE-PUNCTURED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165925 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081466 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown