BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 10099346 · Received May 28, 2020

    Report

    Report Number
    3006948883-2020-00204
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 8, 2020
    Report Date
    June 22, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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 SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9170855. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF A 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. BASED ON THE PHOTOS OF THE DEVICE PROVIDED AND A REVIEW OF THE MANUFACTURING PROCESS, WE HAVE DETERMINED THAT THE MOST LIKELY ROOT CAUSE IS RELATED TO THE EXTENDED CONTACT WITH THE MACHINERY DURING MANUFACTURE. TO ADDRESS THIS SITUATION WE HAVE ADDED AN ADDITIONAL COMPONENT TO THE MANUFACTURING PROCESS TO COUNTER ACT THE TILTED COMPONENT PRIOR TO FINAL INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE PROCESS OF CONNECTING THE INFUSION TO EXHAUST, THE NURSE FOUND THAT A SERIOUS LEAKAGE WAS OCCURED AT THE CONNECTION OF THE HEPARIN CAP, SO SHE STOPPED USING IT AND REPLACED THE INDWELLING NEEDLE."

    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 INTIMA-II 24GAX0.75IN PRN SLM NPVC LEAKED AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE PROCESS OF CONNECTING THE INFUSION TO EXHAUST, THE NURSE FOUND THAT A SERIOUS LEAKAGE WAS OCCURED AT THE CONNECTION OF THE HEPARIN CAP, SO SHE STOPPED USING IT AND REPLACED THE INDWELLING NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558633 INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9170855

    Patients

    Seq Age Sex Outcome Treatment
    1 Other