BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 22GAX0.75IN PRN/EC SLM

    MDR report key: 8566977 · Received April 30, 2019

    Report

    Report Number
    3006948883-2019-00326
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 15, 2019
    Report Date
    July 18, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    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 8141303. 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. ADDITIONALLY COMPOSITION TESTING DETERMINED THAT THE EMBEDDED MATERIAL IS MOST LIKELY CELLULOSE PROPIONATE AND THE MATERIAL ON THE CANNULA IS MOST LIKELY 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. THE SECOND FOREIGN MATTER WAS IDENTIFIED AS CELLULOSE PROPIONATE; THE PRESENCE OF THIS MATERIAL COULD NOT BE ATTRIBUTED TO THE MANUFACTURING PROCESS DESPITE A COMPLETE REVIEW OF OUR MANUFACTURING PROCESSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 INTIMA-II Y 22GAX0.75IN PRN/EC SLM EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND RUST ONE THE NEEDLE HUB, AND ALSO SOME WHITE FLOCCULENT SUBSTANCES. GOOGLE TRANSLATION: DEPARTMENT NURSES IN THE USE OF PATIENTS BEFORE, OPEN THE PACKAGING, FOUND NEEDLE CAP, NEEDLE SEAT AND OTHER PLACES HAVE RUST COLOR TRACES, BECAUSE DO NOT KNOW WHAT, NURSES DARE NOT CONTINUE TO USE THE NEEDLE FOR PUNCTURE, SO REPORTED TO THE NURSING DEPARTMENT. THE DEPARTMENT OF NURSING FOUND LOCAL REPRESENTATIVES. AND THE DEPARTMENT OF NURSING FOUND A TOTAL OF 6 NEEDLES IN THE STOREROOM IS THE CONDITION (ALREADY UNSEALED) DURING THE UNSEALING PROCESS, THE DISCOVERY OF SOME NEEDLES ON THE WHITE FLOCCULATE.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 INTIMA-II Y 22GAX0.75IN PRN/EC SLM EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND RUST ONE THE NEEDLE HUB, AND ALSO SOME WHITE FLOCCULENT SUBSTANCES. GOGGLE TRANSLATION: DEPARTMENT NURSES IN THE USE OF PATIENTS BEFORE, OPEN THE PACKAGING, FOUND NEEDLE CAP, NEEDLE SEAT AND OTHER PLACES HAVE RUST COLOR TRACES, BECAUSE DO NOT KNOW WHAT, NURSES DARE NOT CONTINUE TO USE THE NEEDLE FOR PUNCTURE, SO REPORTED TO THE NURSING DEPARTMENT. THE DEPARTMENT OF NURSING FOUND LOCAL REPRESENTATIVES. AND THE DEPARTMENT OF NURSING FOUND A TOTAL OF 6 NEEDLES IN THE STOREROOM IS THE CONDITION (ALREADY UNSEALED) DURING THE UNSEALING PROCESS, THE DISCOVERY OF SOME NEEDLES ON THE WHITE FLOCCULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360655 INTIMA-II Y 22GAX0.75IN PRN/EC SLM IV CATHETER FMI BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8141303

    Patients

    Seq Age Sex Outcome Treatment
    1 Other