BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9879251 · Received March 25, 2020

    Report

    Report Number
    3006948883-2020-00099
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 5, 2020
    Report Date
    May 12, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    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 9050921. 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, VISUAL EVALUATION OF THE SUBMITTED PHOTOGRAPH AND THE RESULTING REVIEW OF THE MANUFACTURING PROCESS DETERMINED THAT THE IDENTITY OF THE MATERIAL IS SOLIDIFIED SILICONE. SILICONE IS A MATERIAL USED TO MANUFACTURE THIS DEVICE, AND IS APPLIED TO THE CATHETER AS A LUBRICANT FOR REDUCED RESISTANCE DURING INSERTION. EXCESS APPLICATION OF THE LUBRICANT IS CURRENTLY POSSIBLE DUE TO LIMITATIONS IN THE MANUFACTURING PROCESS. BD IS CURRENTLY INVESTIGATING POTENTIAL PROCESS CHANGES TO ELIMINATE THE OCCURRENCE OF SIMILAR EVENTS H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II Y 24GAX0.75IN PRN/EC SLM CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FOUND OIL ON THE NEEDLE CORE WHEN PREPARING TO USE THE PRODUCT FOR INSPECTION TODAY."

    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 Y 24GAX0.75IN PRN/EC SLM CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FOUND OIL ON THE NEEDLE CORE WHEN PREPARING TO USE THE PRODUCT FOR INSPECTION TODAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344999 INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9050921

    Patients

    Seq Age Sex Outcome Treatment
    1 Other