BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 23392148 · Received October 27, 2025

    Report

    Report Number
    3006948883-2025-00802
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 19, 2025
    Manufacturer
    BECTON DICKINSON
    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#5111372): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY, 2025, AND PACKAGED AT R240 PACKAGE LINE IN MAY, 2025. BATCH SIZE IS (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. 3. 45PSI LEAKAGE TEST IS CARRIED OUT ON THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE IS FOUND AT THE CATHETER. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. 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. SINCE THE DEFECTIVE SAMPLE HAS NOT BEEN RECEIVED, THE RELEVANT TESTS CANNOT BE CARRIED OUT,AND THE STATE OF THE CATHETER DAMAGED IS UNIDENTIFIABLE, SO THE ROOT CAUSE OF THE LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    WHILE PERFORMING A CANNULA INSERTION ON A PEDIATRIC PATIENT, THE NURSE SUCCESSFULLY INSERTED THE CANNULA AND BEGAN ADMINISTERING FLUIDS. HOWEVER, FLUID LEAKAGE WAS OBSERVED. UPON REMOVING THE CANNULA, FLUID OVERFLOW WAS NOTED AT THE CONNECTION POINT BETWEEN THE CANNULA AND THE CATHETER ADAPTER. A REPLACEMENT CANNULA WAS INSERTED FOR THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2794683 INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5111372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown