BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22101828 · Received May 28, 2025

    Report

    Report Number
    3006948883-2025-00156
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    April 25, 2025
    Report Date
    June 9, 2025
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830190
    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

    1. DHR/BHR REVIEW(LOT#4233020): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN SEP 2024, AND PACKAGED AT R240 PACKAGE LINE IN SEP 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)THE PRN BATCHES USED IN THIS BATCH OF PRODUCTS ARE 4236069 AND 4243844, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 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#383019 IS AN INTIMA II PRODUCT (PVC EXTENSION TUBING). THE INTENDED USE FOR THE BD INTIMA II PRODUCT IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS. THE MAXIMUM PRESSURE THE PRODUCT CAN WITHSTAND IS 45 PSI (300KPA), AND THIS PRODUCT HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. IF THE INSTANTANEOUS PRESSURE THROUGH THE PRODUCT EXCEEDS 45PSI, THE PRN HAS THE DEFECTS PROBABILITY OF EXPANSION AND BURST. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE THE PRODUCT IS NOT SUITABLE FOR HIGH-PRESSURE INJECTION, THE ROOT CAUSE OF THE COMPLAINT MAY BE RELATED TO THE INCORRECT 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 AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM HAD LEAKAGE WITH POWER INJECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, DURING ENHANCED CT, THE PRN AUTOMATICALLY BURST DURING THE INJECTION OF THE CONTRAST AGENT, SPRAYING THE CONTRAST AGENT ON THE PATIENT AND HIS FAMILY MEMBERS, AND THE CT WAS SUSPENDED. THE CANNULA WAS REPLACED, AND THE CONTRAST AGENT WAS REUSED TO PERFORM THE ENHANCED CT AGAIN. INJURY PERFORMANCE WASTE OF CONTRAST AGENT AND PROLONGED DIAGNOSIS AND TREATMENT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598480 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 4233020 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown