BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10976993 · Received December 9, 2020

    Report

    Report Number
    3006948883-2020-00924
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 12, 2020
    Report Date
    January 12, 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

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140318. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC EXPERIENCED DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER SUCCESSFUL PUNCTURE, THE TUBE LEAKED BLOOD AND THE TUBE WAS DAMAGED A THIRD OF THE CATHETER TUBE WAS BROKEN NEAR THE CATHETER ADAPTER AND BLED. THE PATIENT WAS EXPOSED TO BLOOD, AND PART OF BLOOD FLOWED TO THE PATIENT'S BODY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC EXPERIENCED DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER SUCCESSFUL PUNCTURE, THE TUBE LEAKED BLOOD AND THE TUBE WAS DAMAGED A THIRD OF THE CATHETER TUBE WAS BROKEN NEAR THE CATHETER ADAPTER AND BLED. THE PATIENT WAS EXPOSED TO BLOOD, AND PART OF BLOOD FLOWED TO THE PATIENT'S BODY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441064 INTIMA-II Y 24GAX0.75IN SS PRN SLM NPVC INTERVASCULAR CATHETER FOZ BD (SUZHOU) 0140318

    Patients

    Seq Age Sex Outcome Treatment
    1