BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20065929 · Received August 26, 2024

    Report

    Report Number
    3002601200-2024-00406
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 23, 2024
    Report Date
    October 10, 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

    DHR/BHR REVIEW LOT#4052015 THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4) EACH. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 800MM SIMULATED CLINICAL LEAKAGE TEST AND 45PSI LEAKAGE TEST. ALL TESTS ARE PASSED, AND NO LEAKAGE IS FOUND AT THE SAMPLE. PLEASE SEE THE ATTACHED TEST REPORTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. 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 THE BD INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED WHEN THE NURSE PERFORMED VENIPUNCTURE, SHE SAW THAT BLOOD FLOWED OUT FROM THE NEEDLE CORE WHEN THE NEEDLE CORE WAS WITHDRAWN, AND SMALL WATER DROPLETS WERE VISIBLE NEAR THE HEPARIN CAP.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269710 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052015 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown