BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 21646279 · Received March 19, 2025

    Report

    Report Number
    3002601200-2025-00124
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 27, 2025
    Report Date
    April 15, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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

    1. THE CUSTOMER DIDN¿T RETURN PHOTOS AND DEFECTIVE SAMPLE. 2. DHR/BHR REVIEW (LOT#4171046): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN JUL 2024, AND PACKAGED AT CFS 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. 3. FUNCTION TEST (45PSI LEAKAGE TEST) IS PERFORMED ON RETAINED SAMPLE OF THE COMPLAINT BATCH, THE RESULT IS QUALIFIED, NO LEAKAGE IS FOUND. 4. SKU# 383012 IS AN INTIMA II PRODUCT (PVC EXTENSION TUBING). THE INTENDED USE FOR THE BD INTIMA II PRODUCT IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS. THE FORCING OF LIQUID THROUGH THE PRODUCT DURING ENHANCED CT MAY CAUSE THE EXTENSION TUBING TO RUPTURE. 5. THIS PRODUCT (SKU# 383012) HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): SINCE NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, AND THIS PRODUCT IS NOT SUITABLE FOR HIGH-PRESSURE INJECTION, THE ROOT CAUSE OF THE SUDDEN BREAKAGE OF THE EXTENSION TUBING DURING ENHANCED CT IS RELATED TO THE WRONG USE OF THE PRODUCT.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM TUBING WAS DEFECTIVE/DAMAGED EXTENSION TUBE RUPTURED WHILE DOING AN ENHANCED CT, NEED TO MAKE A CLAIM, NEED A COMPLAINT RESPONSE LETTER, NEED A COMPLAINT RECEIPT LETTER. DEFECTIVE PRODUCT CAN BE RETURNED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688742 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171046 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown