BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC

    MDR report key: 18822948 · Received March 1, 2024

    Report

    Report Number
    3002601200-2024-00068
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    January 30, 2024
    Report Date
    April 11, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830558
    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#2042528): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN FEBRUARY 2022, AND PACKAGED AT CFS PACKAGE LINE IN FEBRUARY 2022. 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 BATCH USED IN THIS BATCH OF PRODUCTS IS 2024517, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO ACTUAL SAMPLES AND PHOTOS RETURNED. 3. TAKE THE RETAINED SAMPLE OF THE COMPLAINT 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 CAN WITHSTAND THE PRESSURE OF 45PSI DURING USE. IF THE PRESSURE IS GREATER THAN 45PSI, THE PRN MAY BE DAMAGED. 5. (B)(4) IS A PRODUCT WITH Y PP CONNECTOR, 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 THIS PRODUCT HAS NOT BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, THE ROOT CAUSE OF THE SUDDEN DISCONNECTION OF THE SLEEVE STOPPER OF PAN DURING ENHANCED CT EXAMINATION MAY BE RELATED TO THE WRONG USE OF THE PRODUCT.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW(LOT#2042528): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN FEBRUARY 2022, AND PACKAGED AT CFS PACKAGE LINE IN FEBRUARY 2022. 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 BATCH USED IN THIS BATCH OF PRODUCTS IS 2024517, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO ACTUAL SAMPLES AND PHOTOS RETURNED. 3. TAKE THE RETAINED SAMPLE OF THE COMPLAINT 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 CAN WITHSTAND THE PRESSURE OF 45PSI DURING USE. IF THE PRESSURE IS GREATER THAN 45PSI, THE PRN MAY BE DAMAGED. 5. SKU#383055 IS A PRODUCT WITH Y PP CONNECTOR, 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 THIS PRODUCT HAS NOT BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, THE ROOT CAUSE OF THE SUDDEN DISCONNECTION OF THE SLEEVE STOPPER OF PAN DURING ENHANCED CT EXAMINATION MAY BE RELATED TO THE WRONG USE OF THE PRODUCT.

    Description of Event or Problem · 0

    END CAP DISLODGED BY HIGH-PRESSURE INJECTION. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HEPARIN CAP DETACHED, USING A BD INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ON (B)(6) 2024, DUE TO THE NEED FOR A BOLUS INJECTION OF IOPAMIDOL FOR ENHANCED CT, A CLOSED INTRAVENOUS INDWELLING NEEDLE WAS USED. DURING THE BOLUS INJECTION, THE RUBBER CAP OF THE HEPARIN CAP SUDDENLY DETACHED, CAUSING THE LIQUID TO OVERFLOW. THE INJECTION WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE INDEPENDENTLY PACKAGED HEPARIN CAP CAUSING NO ADVERSE EFFECTS ON PATIENTS."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238350 BD INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 2042528 00382903830558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown