BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20355017 · Received October 2, 2024

    Report

    Report Number
    3002601200-2024-00483
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    August 20, 2024
    Report Date
    October 16, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830190
    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#4052033 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN MARCH 2024, AND PACKAGED AT CFS PACKAGE LINE IN MARCH 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. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR FUNCTIONAL TESTING: 45PSI LEAKAGE TEST. THE TEST IS PASSED, AND NO LEAKAGE OR ABNORMALITY IS FOUND AT THE SAMPLE. PLEASE REFER TO THE ATTACHMENT FOR THE TEST REPORT. 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. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. SINCE THE PRODUCT IS NOT SUITABLE FOR HIGH PRESSURE INJECTION, THE ROOT CAUSE OF THE PRODUCT BURST DURING INJECTING CONTRAST AGENT IS RELATED TO THE USER END.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM LEAKED WITH POWER INJECTOR. ON (B)(6) 2024, THE NURSE WAS ADMINISTERING CONTRAST TO A PATIENT WHEN THE INDWELLING NEEDLE BURST AND FLUID SPILLED OUT, IMMEDIATELY REAPPLIED THE INDWELLING NEEDLE TO THE PATIENT AND REPORTED THE ADVERSE EVENT. ALTHOUGH THERE WAS NO APPARENT HARM TO THE PATIENT ON THIS OCCASION, THERE IS A RISK THAT THE INCIDENT MAY HAVE CAUSED CORRESPONDING PHYSICAL DAMAGE TO THE PATIENT'S BLOOD VESSELS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728026 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052033 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown