BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 20100619 · Received August 29, 2024

    Report

    Report Number
    3002601200-2024-00415
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    June 24, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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

    DHR/BHR REVIEW LOT#3171582. THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JULY 2023, AND PACKAGED AT R240 PACKAGE LINE IN JULY 2023. WORK ORDER QUANTITY WAS (B)(4) EA. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. REVIEW INCOMING INSPECTION RECORDS OF CATHETER, NO ABNORMALITIES. (MATERIAL NUMBER: B5171AAAL, BATCH NUMBER: 3117920, 3094808, 3142540. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR THE RELEVANT FUNCTIONAL TESTS OF THE CATHETER: 45PSI LEAKAGE TEST AND CATHETER PULL FORCE TEST. THE TEST RESULTS SHOW THAT NO LEAKAGE IS FOUND AT THE CATHETER, AND THE CATHETER PULL FORCE IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE REFER TO THE ATTACHED TEST REPORTS. CATHETER BREAK ANALYSIS: THE BREAK OF THE CATHETER OCCURRED DURING THE WITHDRAWAL OF THE STEEL NEEDLE, INDICATING NO DAMAGE, LEAKAGE AND OTHER ABNORMALITIES HAD BEEN FOUND DURING THE INTEGRITY CHECK, EXHAUST PROCESS BEFORE PUNCTURE. THE CATHETER MAY BE BENT AND PENETRATED DURING THE PUNCTURE PROCESS, AND THE FRONT END OF THE CATHETER MAY BE PRESSED DURING THE WITHDRAWAL OF THE STEEL NEEDLE. AFTER THE CATHETER IS PULLED OUT WITH THE STEEL NEEDLE, THE CATHETER APPEARS TO BE BROKEN. THE CATHETER PULLING FORCE WILL BE REDUCED DUE TO PENETRATION. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BASED ON THE ANALYSIS OF AVAILABLE INFORMATION, THE BREAK OF THE CATHETER MAY BE RELATED TO THE PUNCTURE PROCESS AND CANNOT BE CONFIRMED TO BE RELATED TO THE QUALITY OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC CATHETER BROKE/SEPARATED AFTER PLACEMENT. PATIENTS IN THE PAINLESS GASTROENTEROSCOPY BEFORE THE INTRAVENOUS NEEDLE PUNCTURE, THE NURSE WILL BE INTRAVENOUS NEEDLE PUNCTURE INTO THE BLOOD VESSELS, THE PROCESS OF RETREATING THE STEEL NEEDLE, FOUND THAT THE NEEDLE HOSE BROKE, IMMEDIATELY THE NEEDLE HOSE WITH THE STEEL NEEDLE WITH THE PULL OUT, TO THE PATIENT TO DO A GOOD JOB OF EXPLAINING THE COMFORT OF THE WORK, TO OBTAIN AN UNDERSTANDING, AND THEN RE-REPLACED THE SITE OF THE PUNCTURE FOR THE SECOND PUNCTURE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597001 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3171582 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown