BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 11190950 · Received January 18, 2021

    Report

    Report Number
    3006948883-2021-00132
    Event Type
    Malfunction
    Date Received
    January 18, 2021
    Date of Event
    December 28, 2020
    Report Date
    January 29, 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 SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231181. 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, OUR ENGINEERS WERE ABLE TO EVALUATE THE EXPANDED TUBING IN THE PHOTOGRAPH SUBMITTED BY THE FACILITY. BASED ON THEIR EVALUATION AND THE DESCRIPTION OF THE EVENT, THEY WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION. THE BD INTIMA-II IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 INTIMA-II Y 22GAX1.00IN PRN/EC SLM HAD THE PRN LOOSE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE DOCTOR FOUND THAT THE HEPARIN CAP FLEW OUT AND THE CONTRAST LEAKED WHILE HE WAS PUSHING THE CONTRAST AGENT ON THE PATIENT".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 INTIMA-II Y 22GAX1.00IN PRN/EC SLM HAD THE PRN LOOSE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE DOCTOR FOUND THAT THE HEPARIN CAP FLEW OUT AND THE CONTRAST LEAKED WHILE HE WAS PUSHING THE CONTRAST AGENT ON THE PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82007 INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0231181

    Patients

    Seq Age Sex Outcome Treatment
    1