BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15997661 · Received December 16, 2022

    Report

    Report Number
    3014704491-2022-00672
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    October 27, 2022
    Report Date
    December 5, 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, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2053283. 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 THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CLAMP WAS DEFECTIVE AND ALLOWED BLOOD TO FLOW THROUGH EVEN AFTER CLOSING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AT 23:00 ON (B)(6) 2022, WHEN THE NURSE PLACED THE INDWELLING NEEDLE FOR THE PATIENT, IT WAS FOUND THAT THE INDWELLING NEEDLE CLIP STILL HAD BLOOD FLOW WHEN CLOSED, AND THE FAULT WAS NOT ELIMINATED AFTER SIMPLE TREATMENT. THE INDWELLING NEEDLE WAS REMOVED AND ANOTHER INDWELLING NEEDLE WAS REPLACED. THIS FAILURE CAUSED TWO TIMES OF NEEDLE INSERTION, INCREASED THE WORKLOAD OF NURSES AND INCREASED THE DISCOMFORT OF PATIENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097620 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2053283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown