BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC

    MDR report key: 21919077 · Received April 28, 2025

    Report

    Report Number
    3006948883-2025-00106
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    March 12, 2025
    Report Date
    May 22, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830695
    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

    CORRECTION TO PREVIOUSLY FILED INITIAL MDR: HEALTH EFFECT - CLINICAL CODE & HEALTH EFFECT - IMPACT CODE UPDATED AS INFORMATION AVAILABLE THAT NO IMPACT WAS CAUSED. DEVICE EVALUATION: 1. NO ACTUAL SAMPLES AND PICTURES HAVE BEEN RECEIVED FROM CUSTOMER, AND THE SPECIFIC SITE OF THE CATHETER BREAK AND THE STATE OF THE CATHETER BREAK SURFACE CANNOT BE IDENTIFIED. 2. DHR/BHR REVIEW (LOT#2082668): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APR 2022 AND PACKAGED AT R240 PACKAGE LINE IN APR 2022. 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 CATHETER BATCH USED IN THIS BATCH OF PRODUCTS IS 4243848, 4173016, 4264492; REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 3. TAKE THE RETAINED SAMPLE OF THIS BATCH TO CONDUCT THE RELEVANT FUNCTIONAL TESTS OF THE CATHETER. 1) 45PSI LEAKAGE TEST IS CARRIED OUT, AND NO LEAKAGE IS FOUND AT THE CATHETER. 2) CATHETER PULL FORCE TEST IS PERFORMED (TO SIMULATE THE HUMAN ENVIRONMENT, THE SAMPLE NEEDS TO BE SOAKED IN WARM WATER AT 37 ° C FOR 72 HOURS BEFORE TESTING), AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. 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 SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER EXAMINATION AND ANALYSIS, AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE BREAK OF THE CATHETER CANNOT BE CONFIRMED. THE PLANT WILL CONTINUE TO FOLLOW UP THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC CATHETER BROKE INTRAVENOUS INDWELLING NEEDLE CANNULA INTERRUPTED AND BROKEN DURING PUNCTURE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757797 BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 2082668 00382903830695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown