BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12421696 · Received September 3, 2021

    Report

    Report Number
    3014704491-2021-00119
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 5, 2021
    Report Date
    August 23, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140317. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, THE SAMPLE SUBMITTED HAS BEEN REVIEWED BY OUR TEAM OF QUALITY ENGINEERS. LEAKAGE TESTING OF THE DEVICE WAS ABLE TO IDENTIFY A SMALL HOLE IN THE CATHETER TUBING. THE ISSUE HAS BEEN CONFIRMED. FURTHER MICROSCOPIC ANALYSIS OF THE WOUND, REVEALED TELLTALE CHARACTERISTICS CONSISTENT WITH DAMAGE SUSTAINED DURING ASSEMBLY. THE DAMAGE IS DIRECTLY CAUSED BY THE GRIPPERS USED TO SECURE THE TUBING DURING ASSEMBLY. TO PREVENT A REOCCURRENCE OF THIS EVENT OUR ENGINEERS HAVE NOTIFIED THE APPROPRIATE INSPECTION TEAM OF THIS OCCURRENCE AND HAVE POLISHED THE GRIPPER TO REMOVE ANY POSSIBLE BURRS OR IMPERFECTIONS THAT COULD DAMAGE THE TUBING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HOLE IN THE INTIMA-II Y 24GAX0.75IN MZ PRN SLM NPVC TUBE CAUSED BLOOD TO LEAK OUT. THIS OCCURRED WITH 3 CATHETERS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THERE WAS A HOLE ON THE CATHETER TUBE" "CATHETER TUBING WAS DISCOVERED DURING THE PUNCTURE PROCESS DUE TO BLOOD LEAKING FROM THE HOLE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322558 INTIMA-II Y 24GAX0.75IN MZ PRN SLM NPVC INTRAVASCULAR CATHETER FOZ 0140317

    Patients

    Seq Age Sex Outcome Treatment
    1