BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20034007 · Received August 22, 2024

    Report

    Report Number
    3002601200-2024-00397
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 19, 2024
    Report Date
    September 10, 2024
    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

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

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 3 PHOTOS, NO DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT THE SKU IS 383012, THE BATCH CODE IS 3052815, AND THE SLEEVE STOPPER OF THE PRN HAS BEEN FALLEN OFF. 2. DHR/BHR REVIEW LOT#3052815. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2023, AND PACKAGED AT CFS PACKAGE LINE IN APRIL 2023. 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. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR RELEVANT FUNCTIONAL TESTING 1-45PSI LEAKAGE TEST IS PERFORMED, NO LEAKAGE IS FOUND, AND NO ABNORMALITY IS FOUND ON THE PRN. 2-PRN PULL FORCE TEST I.E., TEST THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING IS CARRIED OUT, AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT FOR THE TEST REPORTS. 4. THE PRN IS ONLY SUITABLE FOR NORMAL PRESSURE (I.E. LESS THAN 45PSI, 300KPA) INFUSION. HIGH PRESSURE INJECTION CAN CAUSE DAMAGE TO THE PRN. 5. SKU# 383012 IS AN INTIMA II PRODUCT, THE INTENDED USE IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS, WHICH HAS NOT 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): NO ABNORMALITY IS 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 SLEEVE STOPPER OF THE PRN BEING WASHED AWAY AND FALLEN OFF IS RELATED TO THE WRONG USE OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED WITH POWER INJECTION. ON (B)(6) 2024, THE PATIENT CAME TO OUR HOSPITAL FOR FURTHER TREATMENT OF ¿DIZZINESS AND CHEST TIGHTNESS FOR MORE THAN A WEEK¿, AND WAS ADMITTED TO THE OUTPATIENT CLINIC WITH ¿CEREBRAL ARTERIAL HYPOPERFUSION¿. DUE TO THE CLINICAL SITUATION, A CRANIAL CTA EXAMINATION WAS ARRANGED, AND BEFORE THE CRANIAL CTA EXAMINATION WAS PERFORMED ON (B)(6) 2024, THE HEPARIN CAP OF THE INDWELLING NEEDLE WAS WASHED AWAY AND FELL OFF DURING THE INJECTION OF THE CONTRAST AGENT IOHEXOL INJECTION WITH A HIGH-PRESSURE SYRINGE, SO THE INJECTION OF THE CONTRAST AGENT WAS SUSPENDED WITH THE HIGH-PRESSURE SYRINGE, AND THE ONE-HANDED CLAMP WAS CLOSED IN A TIMELY MANNER, AND THEN THE HEPARIN CAP OF THE SAME BATCH OF THE CLOSED INTRAVENOUS NEEDLE WAS REPLACED, AND THE INJECTION OF THE CONTRAST AGENT WAS RESUMED AND THE EXAMINATION WAS COMPLETED. IN THIS INCIDENT, WHEN THE HEPARIN CAP WAS WASHED OFF, FIRST ALL OF THE CONTRAST AGENT FLOWED OUT, AND THEN THE PATIENT'S VENOUS REFLUX FLOWED OUT, RESULTING IN A WASTE OF CONTRAST AGENT AND BLEEDING FROM THE PATIENT'S VEINS. THIS IS AN ISOLATED CASE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMAITON PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26679 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3052815 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown