BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20632554 · Received November 7, 2024

    Report

    Report Number
    3002601200-2024-00589
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 2, 2024
    Report Date
    October 17, 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

    DHR/BHR REVIEW LOT#2053283. THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MARCH 2022, AND PACKAGED AT R240 PACKAGE LINE IN MARCH 2022. WORK ORDER QUANTITY WAS (B)(4) EACH. 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. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN, AND THE SURFACE OF THE CATHETER IS EXAMINED UNDER THE MICROSCOPE. NO ABNORMALITY IS FOUND. PENETRATION FORCE TEST IS CARRIED OUT ON THE SAMPLE, THE NEEDLE TIP PENETRATION FORCE, CATHETER TIP PENETRATION FORCE AND CATHETER DRAG FORCE ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION: NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BECAUSE THE ABNORMAL STATES OF THE CATHETER CANNOT BE IDENTIFIED, THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC CATHETER DEFECTIVE/DAMAGED AT THE TIME OF USE, IT WAS FOUND THAT THE POSTERIOR SECTION OF THE INDWELLING NEEDLE HOSE HAD A BULGE THAT PREVENTED SMOOTH NEEDLE ENTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796811 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 2053283 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown