BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10674070 · Received October 13, 2020

    Report

    Report Number
    3006948883-2020-00557
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 17, 2020
    Report Date
    November 23, 2020
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8043015. 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. UNFORTUNATELY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MEDICAL TREATMENT ON (B)(6) DUE TO THE INSUFFICIENCY OF CEREBRAL ARTERY BLOOD SUPPLY. ON (B)(6), THE PATIENT WAS TREATED WITH CLOSED VENOUS INDWELLING NEEDLE INFUSION. AT 08:00 ON (B)(6), A LITTLE BLOOD OOZED FROM THE INITIAL SITE WAS FOUND DURING INFUSION, AND THE INTRAVENOUS INDWELLING NEEDLE WAS REPLACED IN TIME.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MEDICAL TREATMENT ON SEPTEMBER 15 DUE TO THE INSUFFICIENCY OF CEREBRAL ARTERY BLOOD SUPPLY. ON (B)(6), THE PATIENT WAS TREATED WITH CLOSED VENOUS INDWELLING NEEDLE INFUSION. AT 08:00 ON (B)(6), A LITTLE BLOOD OOZED FROM THE INITIAL SITE WAS FOUND DURING INFUSION, AND THE INTRAVENOUS INDWELLING NEEDLE WAS REPLACED IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134312 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8043015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other