BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11868466 · Received May 23, 2021

    Report

    Report Number
    3006948883-2021-00588
    Event Type
    Malfunction
    Date Received
    May 23, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 24, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140318 . 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 RETURNED TO OUR FACILITY HAS BEEN REVIEWED BY OUR TEAM OF ENGINEERS. THROUGH MICROSCOPIC INSPECTION THEY WERE ABLE TO IDENTIFY CHARACTERISTICS ON THE SURFACE OF THE CATHETER TUBING THAT IS CONSISTENT WITH ABRASIONS KNOWN TO BE GENERATED BY THE MANUFACTURING PROCESS. AFTER A REVIEW OF THE MANUFACTURING LINE A PAIR OF CLAMPS, WHICH ARE USED TO TRANSFER THE PARTIALLY ASSEMBLED DEVICE BETWEEN STATIONS, WAS IDENTIFIED AS HAVING SUFFERED FROM WEAR FROM OVERUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC HAD A HOLE IN THE CATHETER AND CONTRIBUTED TO A BLOOD SPLASH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WHEN THE NURSE IN GENERAL SURGERY DEPARTMENT OF CILIN HOSPITAL USED 24G RUIMA-S PUNCTURE FOR THE PATIENT, HE SAW BLOOD RETURN AND FOUND THAT WANLONG CATHETER TUBING HAD A SMALL HOLE AND BLOOD OOZING OUT OF THE TUBE WALL. THE NURSE EXTUBATED IT WITHOUT CAUSING HARM TO THE PATIENT OR OTHERS."

    Additional Manufacturer Narrative · 1

    " A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC HAD A HOLE IN THE CATHETER AND CONTRIBUTED TO A BLOOD SPLASH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WHEN THE NURSE IN GENERAL SURGERY DEPARTMENT OF CILIN HOSPITAL USED 24G RUIMA-S PUNCTURE FOR THE PATIENT, HE SAW BLOOD RETURN AND FOUND THAT WANLONG CATHETER TUBING HAD A SMALL HOLE AND BLOOD OOZING OUT OF THE TUBE WALL. THE NURSE EXTUBATED IT WITHOUT CAUSING HARM TO THE PATIENT OR OTHERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764942 INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0140318

    Patients

    Seq Age Sex Outcome Treatment
    1