BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 11168512 · Received January 13, 2021

    Report

    Report Number
    3006948883-2021-00091
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    February 23, 2021
    Manufacturer
    BD (SUZHOU)
    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 0140313. 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. IT CAN BE SEEN FROM THE RETURNED PICTURE THAT THERE IS WHITE FOREIGN BODY IN THE INDWELLING NEEDLE SURFACE. THE RESULTING REVIEW OF THE MANUFACTURING PROCESS AND RETAIN SAMPLES 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. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS VISIBLE SILLICON PARTICLE IN THE NEEDLE, AND THIS INCCIDENT WAS HAPPENED IN THE DEPARTMENT OF PSYCHIATRY.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140313. 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. BD IS CURRENTLY INVESTIGATING POTENTIAL PROCESS CHANGES TO ELIMINATE THE OCCURRENCE OF SIMILAR EVENTS. INVESTIGATION CONCLUSION: IT CAN BE SEEN FROM THE RETURNED PICTURE THAT THERE IS WHITE FOREIGN BODY IN THE INDWELLING NEEDLE SURFACE . NO ACTUAL SAMPLE RETURNED, THE WHITE SUBSTANCE ON THE NEEDLE SURFACE CANNOT BE CONFIRMED BY CHEMICAL COMPOSITION ANALYSIS. NEEDLE SILICONE OIL INVESTIGATION: ACCORDING TO THE CHARACTERISTICS OF SILICONE, DURING THE HIGH TEMPERATURE AND HUMIDITY , THERE MAY BE A LITTLE PRECIPITATE ON THE NEEDLE . BD'S MATERIALS LABORATORY IN THE UNITED STATES CONDUCTS A NORMATIVE TEST ON THE SILICONE USED IN THE PRODUCT PROCESS. THE TEST RESULTS SHOW THAT THE SILICONE IS A LUBRICANT FOR MEDICAL DEVICE PRODUCTS AND MEETS THE REQUIREMENTS OF RELEVANT ISO AND FDA STANDARDS. CHECK THE BATCH RECORD, RECORD OF IN-PROCESS INSPECTION AND FINAL INSPECTION. NO FINING ON RESIDUAL OF SILICONE ON THE NEEDLE. THE SILICONE IS A LUBRICANT FOR MEDICAL DEVICE PRODUCTS ,THE SUBSTANCE IS NON-TOXIC AND HARMLESS MEETS THE REQUIREMENTS OF RELEVANT ISO AND FDA STANDARDS. THE FACTORY WILL CONTINUE TO MONITOR SUCH DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II" CLOSED IV CATHETER SYSTEM EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS VISIBLE SILLICON PARTICLE IN THE NEEDLE, AND THIS INCCIDENT WAS HAPPENED IN THE DEPARTMENT OF PSYCHIATRY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64766 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 0140313

    Patients

    Seq Age Sex Outcome Treatment
    1