BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17814557 · Received September 25, 2023

    Report

    Report Number
    3014704491-2023-00596
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    September 10, 2023
    Report Date
    November 15, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    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. THE CUSTOMER RETURNED 1 USED SAMPLE, THE SKU IS 383028, THE BATCH CODE IS 3017073. 1)THE SAMPLE IS EXAMINED UNDER MICROSCOPE, AND IT IS FOUND THAT THE MIDDLE OF THE EXTENSION TUBING IS BROKEN, THE BREAK AREA ACCOUNTS FOR ABOUT THREE-QUARTERS OF THE CROSS SECTION OF THE EXTENSION TUBING, THE BREAK SURFACE IS CONCAVE FROM OUTSIDE TO INSIDE, AND THERE IS NO CLAMP MARK OR DAMAGE ON THE SURFACE OF THE EXTENSION TUBING WHERE IT IS NOT BROKEN. THE CLAMPING PARTS OF THE PINCH CLAMP ARE SMOOTH AND FREE OF BURRS AND OTHER ABNORMALITIES, THE TWO CLASPS OF THE PINCH CLAMP ARE NOT CENTERED. 2)THE ID AND OD OF THE EXTENSION TUBING ARE MEASURED, AND THE RESULTS ARE WITHIN THE PRODUCT SPECIFICATIONS. 3)THE PINCH CLAMP SEALING PRESSURE TEST IS CARRIED OUT (TEST PROCESS: THE EXTENSION TUBING IS CLAMPED IN THE SAME POSITION FOR MORE THAN 64 TIMES, AND THEN KEPT IN THE CLAMPED STATE UNDER 800MM PRESSURE DEVICE FOR 3 DAYS). THE TEST RESULT: NO LEAKAGE OR DAMAGE IS FOUND IN THE EXTENSION TUBING. 2. DHR/BHR REVIEW(LOT#3017073): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN FEBRUARY 2023, AND PACKAGED AT R240 PACKAGE LINE IN FEBRUARY 2023. WORK ORDER QUANTITY WAS 99,000 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 EXTENSION TUBING BATCH USED IN THIS BATCH OF PRODUCTS IS 3012853, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 5)THE PINCH CLAMP BATCH USED IN THIS BATCH OF PRODUCTS IS 2335839, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR THE SEALING PRESSURE TEST OF THE PINCH CLAMP AND THE DETECTION OF THE ID AND OD OF THE EXTENSION TUBING. NO ABNORMALITY IS FOUND IN THE TEST RESULTS, PLEASE SEE ATTACHMENT PR#8866799-3 FOR THE TEST REPORTS. 4. CAUSE ANALYSIS: 1)ANALYSIS FROM THE BREAK STATE OF THE EXTENSION TUBING: THE EXTENSION TUBING HAS NOT BEEN CLAMPED IN THE CENTER OF THE PINCH CLAMP. 2)JUDGING FROM THE TWO CLASPS OF THE PINCH CLAMP ARE NOT CENTERED: THE TWO CLASPS OF THE PINCH CLAMP HAVE BEEN MISALIGNED WHEN CLAMPED. 3)WE SIMULATE THE CLAMPING STATE OF SUCH AS APPEAL, AND FIND THAT THERE WILL BE SOME DAMAGE TO THE EXTENSION TUBING, BUT IT WILL NOT CAUSE THE BREAK. 5. 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. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. NO QUALITY PROBLEMS ARE DETECTED IN THE EXTENSION TUBING AND PINCH CLAMP OF THE RETURNED SAMPLE, AND IT IS IDENTIFIED FROM THE DEFECT STATE OF THE RETURNED SAMPLE THAT THE EXTENSION TUBING HAS NOT BEEN CLAMPED IN THE CENTER OF THE PINCH CLAMP, AND THE TWO CLASPS OF THE PINCH CLAMP HAVE BEEN MISALIGNED WHEN CLAMPED. HOWEVER, DUE TO THE FAILURE TO SIMULATE THE EXTENSION TUBING BREAK, IT IS JUDGED THAT THE SUPERPOSITION OF OTHER FACTORS CAUSED THE EXTENSION TUBING BREAK, AND THE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE UNKNOWN USAGE OF THE INDWELLING NEEDLE. THIS COMPLAINT IS AN ISOLATED CASE, AND THE PLANT WILL CONTINUE TO TRACK MONITOR THE ISSUE.

    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.

    Description of Event or Problem · 0

    WHEN THE NURSE WAS GIVING INFUSION, SHE OPENED THE TUBE SEALING CLAMP AND THE PART WHERE THE TUBE SEALING CLAMP WAS CLAMPED BROKE. PERFORM PUNCTURE INFUSION WITH REPLACEMENT OF THE INDWELLING NEEDLE. THE NURSE REPORTED THAT THE INDWELLING NEEDLE WAS USED IN THE MORNING, AND THE EXTENSION TUBE WAS BROKEN DURING THE SECOND INFUSION IN THE AFTERNOON.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THE TUBING WAS DAMAGED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE NURSE WAS GIVING INFUSION, SHE OPENED THE TUBE SEALING CLAMP AND THE PART WHERE THE TUBE SEALING CLAMP WAS CLAMPED BROKE. PERFORM PUNCTURE INFUSION WITH REPLACEMENT OF THE INDWELLING NEEDLE. THE NURSE REPORTED THAT THE INDWELLING NEEDLE WAS USED IN THE MORNING, AND THE EXTENSION TUBE WAS BROKEN DURING THE SECOND INFUSION IN THE AFTERNOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440497 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3017073 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown