BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15637131 · Received October 20, 2022

    Report

    Report Number
    3014704491-2022-00499
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    September 15, 2022
    Report Date
    October 24, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2011052. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2011052. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED 2 CASES OF CATHETER HUB DAMAGE, AND AN UNSPECIFIED NUMBER OF CASES OF FOREIGN MATTER ON THE DEVICE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HEAD NURSE OF CARDIOVASCULAR MEDICINE REPORTED THAT THE SURFACE WAS UNEVEN WITH SMALL WHITE SPOTS WHEN THE PRODUCT WAS OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED 2 CASES OF CATHETER HUB DAMAGE, AND AN UNSPECIFIED NUMBER OF CASES OF FOREIGN MATTER ON THE DEVICE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HEAD NURSE OF CARDIOVASCULAR MEDICINE REPORTED THAT THE SURFACE WAS UNEVEN WITH SMALL WHITE SPOTS WHEN THE PRODUCT WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2804706 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2011052

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown