BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10105706 · Received June 1, 2020

    Report

    Report Number
    3006948883-2020-00206
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    May 7, 2020
    Report Date
    June 22, 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

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9170852. 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 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 BLOOD LEAKED FROM THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM DURING USE ON A PATIENT BEING TREATED FOR "ACUTE BRONCHITIS". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE PATIENT WAS TREATED WITH INTRAVENOUS INFUSION DUE TO ACUTE BRONCHITIS ON THE MORNING OF (B)(6) 2020. AFTER PUNCTURING AND CATHETERIZATION, THE BLOOD RETURNED AND LEAKED OUT FROM PRN . THE NURSE WAS IMMEDIATELY CLIPPED AND REPLACED WITH HEPARIN, AFTER THAT THE INFUSION WAS SUCCESSFUL COMPLETION."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM DURING USE ON A PATIENT BEING TREATED FOR "ACUTE BRONCHITIS". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE PATIENT WAS TREATED WITH INTRAVENOUS INFUSION DUE TO ACUTE BRONCHITIS ON THE MORNING OF (B)(6) 2020. AFTER PUNCTURING AND CATHETERIZATION, THE BLOOD RETURNED AND LEAKED OUT FROM PRN . THE NURSE WAS IMMEDIATELY CLIPPED AND REPLACED WITH HEPARIN, AFTER THAT THE INFUSION WAS SUCCESSFUL COMPLETION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571031 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9170852

    Patients

    Seq Age Sex Outcome Treatment
    1 Other