BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II

    MDR report key: 21807328 · Received April 9, 2025

    Report

    Report Number
    3006948883-2025-00060
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 22, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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#4171125): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JUL 2024, AND PACKAGED AT R240 PACKAGE LINE IN JUL 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 45PSI LEAKAGE TEST, THE TEST IS PASSED AND NO LEAKAGE IS FOUND. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. BECAUSE DEFECTIVE SAMPLES WERE NOT RETURNED, THE SPECIFIC LEAKAGE SITE AND ABNORMAL STATE OF THE DEFECTIVE SAMPLE CANNOT BE IDENTIFIED, SO THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED.THE PLANT WILL CONTINUE TO TRACK AND MONITOR THE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II LEAKED DURING THE INFUSION PROCESS OF AN ELDERLY PATIENT, A LIQUID LEAK WAS DISCOVERED, WHICH AFFECTED THE PATIENT'S MOOD DURING TREATMENT. AFTER COMMUNICATION, THE INDWELLING NEEDLE WAS REPLACED, WHICH INCREASED THE PATIENT'S SUFFERING.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383333 BD INTIMA-II INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown