BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10099292 · Received May 28, 2020

    Report

    Report Number
    3006948883-2020-00203
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 8, 2020
    Report Date
    June 15, 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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9233912. 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. BASED ON OUR REVIEW OF THE PROVIDED PHOTOGRAPH OUR ENGINEERS HAVE DETERMINED THAT THE FOREIGN MATERIAL IS EMBEDDED IN THE RAW MATERIAL OF THE HEPARIN CAP. THE MOST LIKELY ROOT CAUSE FOR THIS OCCURRENCE IS RELATED TO OPERATOR AWARENESS DURING THE MANUAL INSPECTION OF HE INCOMING RAW MATERIAL FOR THE HEPARIN CAPS. TO ADDRESS THIS ISSUE WE HAVE ISSUED AN EMPLOYEE TRAINING TO INCREASE OPERATOR VIGILANCE DURING THE INSPECTION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN OPENING THE PACKAGE BEFORE USING, THERE WAS SOME DIRT ON THE PRN SURFACE OF THE INDWELLING NEEDLE. THE CHIEF NURSE TOOK THE PICTURE AND STORED THE PRODUCT AT THE FIRST TIME."

    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 PRN EC SLM NPVC CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN OPENING THE PACKAGE BEFORE USING, THERE WAS SOME DIRT ON THE PRN SURFACE OF THE INDWELLING NEEDLE. THE CHIEF NURSE TOOK THE PICTURE AND STORED THE PRODUCT AT THE FIRST TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558635 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9233912

    Patients

    Seq Age Sex Outcome Treatment
    1 Other