BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 18567341 · Received January 23, 2024

    Report

    Report Number
    3014704491-2024-00030
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    November 24, 2023
    Report Date
    March 12, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    UDI-DI
    00382903830282
    PMA / PMN Number
    NA
    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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW(LOT#3080077): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2023, AND PACKAGED AT R240 PACKAGE LINE IN MAY 2023. 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. 4)THE PRN BATCHES USED IN THIS BATCH OF PRODUCTS ARE 3094803, 3113566, 3083066, 3083068, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN AND THE PRN IS CONDUCTED ON THE SELF- TIGHTNESS TEST AFTER PENETRATION (TEST PROCESS: PENETRATION SLEEVE STOPPER 100 TIMES, THEN, TO PERFORM THE LEAKAGE TEST). THE TEST IS PASSED AND NO LEAKAGE IS FOUND AT THE PENETRATION SITE OF THE PRN. PLEASE SEE 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 ABOUT THIS BATCH OF PRODUCTS. AS NO COMPLAINED SAMPLE IS RECEIVED, THE DEFECT OF THE PRN CANNOT BE ANALYZED, SO THE ROOT CAUSE OF THE LEAKAGE AT THE PENETRATION SITE OF THE PRN CANNOT BE CONFIRMED. H3 OTHER TEXT : SEE NARRATIVE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NTIMA-II 24GAX0.75IN PRN SLM NPVC WAS LEAKING AT ADAPTER TUBING JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: 'A CHILD WAS ADMITTED TO THE EMERGENCY DEPARTMENT FOR SURGICAL TREATMENT ON (B)(6) 2023, AND WAS GIVEN AN INDWELLING VEIN BEFORE SURGERY. ON THE MORNING OF (B)(6)2024, FLUID WAS FOUND TO BE OOZING OUT OF THE HEPARIN CAP OF THE INDWELLING NEEDLE AT THE PUNCTURE POINT OF THE SCALP NEEDLE, SO THE HEPARIN CAP WAS REPLACED IMMEDIATELY, AND THERE WAS NO OOZING AFTER THE REPLACEMENT.'

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855395 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 3080077 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown