BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II

    MDR report key: 8566978 · Received April 30, 2019

    Report

    Report Number
    3006948883-2019-00325
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 15, 2019
    Report Date
    May 31, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    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: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7048122. 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 SAMPLES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 40 22G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II EXPERIENCED FOREIGN MATER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND SOME WHITE FLOCCULENT SUBSTANCES.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 40 22G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II EXPERIENCED FOREIGN MATER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND SOME WHITE FLOCCULENT SUBSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360656 22G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 7048122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other