BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15756959 · Received November 8, 2022

    Report

    Report Number
    3014704491-2022-00554
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    September 21, 2022
    Report Date
    October 28, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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

    INITIAL REPORTER E-MAIL: UNKNOWN. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2110886. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING CLAMP ON THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS DEFECTIVE AND COULDN'T BE CLAMPED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "IN THE AFTERNOON, THE PATIENT WAS GIVEN FLUIDS, AND THE INDWELLING NEEDLE WAS OPENED FOR PUNCTURE. AFTER THE PUNCTURE WAS COMPLETED, IT WAS FOUND THAT THE INDWELLING NEEDLE CLAMP COULD NOT BE CLAMPED. AFTER COMMUNICATION AND EXPLANATION WITH THE PATIENT, THE INDWELLING NEEDLE WAS PULLED OUT AND THE CATHETER WAS RE-INSERTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456235 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2110886 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown