BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 15794634 · Received November 14, 2022

    Report

    Report Number
    3014704491-2022-00566
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 8, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    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

    INVESTIGATION SUMMARY 1. NO ACTUAL SAMPLES AND PICTURES WERE RECEIVED FROM CUSTOMER, AND THE DEFECT STATUS CANNOT BE CONFIRMED. AFTER THE PRODUCT WAS INDWELLED FOR 5 MINUTES, THE IMPLANTATION SITE LEAKED, INDICATING THAT NO ABNORMALITY WAS FOUND IN THE INTEGRITY CHECK AND EXHAUST PROCESS OF THE INDWELLING NEEDLE. 2. DHR/BHR REVIEW(LOT#2172309): 1)THE PRODUCT GAUGE IS 24G, ASSEMBLY AT AUTO LINE 4 IN JUL. 2022, PACKAGING AT CFS PACKING MACHINE IN JUL. 2022, BATCH QUANTITY IS 198K. 2)REVIEW THE IN-PROCESS TEST REPORT AND OUTGOING TEST REPORT, TEST RESULTS ALL MEET THE PRODUCT SPECIFICATIONS, NO ABNORMALITIES. 3)REVIEW THE PRODUCTION RECORDS, NO NONCONFORMANCE, DEVIATIONS OR REWORK ACTIVITIES. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTS. (SEE ATTACHMENT PR#6347909-1 FOR TEST REPORT) 1)PENETRATION FORCE TEST IS PERFORMED, THE NEEDLE TIP, CATHETER TIP AND CATHETER DRAG FORCE ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. 2)LIE DISTANCE IS MEASURED AND NO ABNORMALITY IS FOUND. 4. THE REASON OF LEAKAGE AT THE IMPLANTATION SITE IS COMPLICATED. THE USUAL REASONS ARE AS BELOW: 1)PUNCTURE ANGLE IS SO SMALL THAT THE PUNCTURE WOUND IS RELATIVELY BIG. IT IS SUGGESTED THAT THE NURSE SHOULD HAND THE PRODUCT WITH BEVEL OF NEEDLE TIP UPWARD AND PUNCTURE IN 15°~30° AT INSERTION SITE, PRESS THE NEEDLE DOWN IN 5°~10° TO INSERT AFTER SEEING BLOOD RETURN. (SEE ATTACHMENT PR#6347909-2 FOR THE ANGLE VIEW OF THE NEEDLE INSERTION) 2) THE MEDICAL DRESSING ISN¿T APPLIED CORRECTLY, WHICH LEAD TO LEAKAGE WHEN THE PRODUCT MOVES RELATIVE TO INSERTION SITE. IT IS SUGGESTED THAT THE NURSE SHOULD HAND THE MEDICAL DRESSING WITHOUT TENSION, PLACE IT CORRECTLY, PINCH THE CATHETER HUB TO ENSURE FULLY FIXED BY THE MEDICAL DRESSING AND THEN PASTE TO THE PERIPHERY. (SEE ATTACHMENT PR#6347909-3 FOR APPLICATION METHOD VIEW) 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND THE RETAINED SAMPLE; NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE RETURNED, AND THE USAGE IS UNKNOWN, THE ROOT CAUSE OF LEAKAGE AT THE IMPLANTATION SITE CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II CLOSED IV CATHETER SYSTEM LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AT ABOUT 10:30 ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH AN INTRAVENOUS INDWELLING NEEDLE, AND THE DIURETIC MIXTURE WAS PUMPED. AFTER 5 MINUTES, THE INDWELLING NEEDLE WAS FOUND TO BE LEAKING AT THE IMPLANTATION SITE, AND THE INDWELLING NEEDLE WAS RE-IMPLANTED TO COMPLETE THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262588 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2172309

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown