BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 22101681 · Received May 28, 2025

    Report

    Report Number
    3006948883-2025-00155
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    April 24, 2025
    Report Date
    June 9, 2025
    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

    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#4243812): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN SEP, 2024, AND PACKAGED AT R240 PACKAGE LINE IN SEP, 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. 4)THE EXTENSION TUBING BATCHES USED IN THIS BATCH OF PRODUCTS IS 4236035, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED, THE SPECIFIC SITE AND DAMAGE STATE OF THE BREAK OF THE EXTENSION TUBING CANNOT BE IDENTIFIED. 3. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR RELEVANT FUNCTIONAL TESTS: THE PULL STRENGTH TEST BETWEEN THE EXTENSION TUBING AND THE PP CONNECTOR, AND THE PULL STRENGTH TEST BETWEEN THE EXTENSION TUBING AND THE CATHETER HUB. THE TEST RESULTS ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. 4. THE BREAK OF THE EXTENSION TUBE OCCURRED ON THE FOURTH DAY OF PLACEMENT, INDICATING THAT THE INDWELLING NEEDLE WAS NORMAL BOTH BEFORE AND DURING USE, WHILE ALSO STATING THAT THERE WERE NO QUALITY ISSUES WITH THE INDWELLING NEEDLE PRODUCT. 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 SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. AS THE DEFECTIVE SAMPLE HAS NOT BEEN RETURNED , THE RELEVANT TESTS CANNOT BE PERFORMED,AND THE BREAK OF THE EXTENSION TUBE OCCURRED ON THE FOURTH DAY OF PLACEMENT, THE USAGE STATUS OF THE SAMPLE DURING THIS PERIOD IS UNKNOWN,SO THE ROOT CAUSE OF THE BREAK OF THE EXTENSION TUBING CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II 24GAX0.75IN PRN SLM TUBING WAS DEFECTIVE / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, ON THE FOURTH DAY OF THE PATIENT'S CANNULA INFUSION, THE CANNULA WAS FRACTURED AT THE EXTENSION TUBING. IT WAS REMOVED AND ROUTINE FLUIDS WERE ADMINISTERED. THE PATIENT INCURRED NO INJURIES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709704 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 4243812 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown