BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21827331 · Received April 11, 2025

    Report

    Report Number
    3006948883-2025-00068
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 25, 2025
    Report Date
    June 25, 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#4142708): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN JUNE 2024, AND PACKAGED AT R245 PACKAGE LINE IN JUNE 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. 4)REVIEW INCOMING INSPECTION RECORDS OF SMARTSITE, NO ABNORMALITIES. (MATERIAL NUMBER: PC5000R, BATCH NUMBER:23118097 AND 23114035) 5)ACCORDING TO THE PRODUCTION INFORMATION PROVIDED BY THE TIJUANA FACTORY IN MEXICO: THE PRODUCTION TIME OF BATCH 23118097 IS NOVEMBER 2023, WITH A PRODUCTION QUANTITY OF (B)(4) PCS, AND THE PRODUCTION TIME OF BATCH 23114035 IS ALSO NOVEMBER 2023, WITH A PRODUCTION QUANTITY OF (B)(4) PCS. 2.THE CUSTOMER RETURNS 1 PHOTO, NO DEFECTIVE SAMPLE. PHOTOGRAPHS SHOW FLUID OOZING FROM THE SMARTSITE COMPONENT OF THE INDWELLING NEEDLE. 3.THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR VISUAL INSPECTION, NO ABNORMALITIES WERE FOUND,AND TAKEN FOR 45PSI LEAKAGE TEST, THE TEST IS PASSED, AND NO LEAKAGE IS FOUND. 4. NO SAME COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. 5. THE SUZHOU PLANT CONTACTED THE TIJUANA FACTORY IN MEXICO (A SMARTSITE SUPPLIER) AND THEY PROVIDED THE PRODUCTION INFORMATION OF THE SMARTSITE BATCH USED IN THE COMPLAINT BATCH. THERE WAS NO QN DURING THE PRODUCTION PROCESS.AS NO SAMPLES WERE RETURNED, FURTHER ANALYSIS COULD NOT BE CARRIED OUT. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND THE RETAINED SAMPLES.THE RETURNED PHOTO SHOWS LEAKAGE OCCURRED AT THE SMARTSITE CONNECTOR, SINCE NO DEFECTIVE SAMPLE HAS BEEN RECEIVED FOR RELEVANT TESTS, AND THE USAGE OF THE SAMPLE IS UNKNOWN, 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

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN SS PRN SLM NPVC LEAKED LEAKAGE FROM INDWELLING NEEDLE CONNECTOR.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269786 BD INTIMA-II Y 22GAX1.00IN SS PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4142708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown