BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8191458 · Received December 21, 2018

    Report

    Report Number
    1710034-2018-00960
    Event Type
    Death
    Date Received
    December 21, 2018
    Date of Event
    October 25, 2018
    Report Date
    January 3, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE CATALOG #: CUSTOMER UNABLE TO DETERMINE IF THE DEVICE THAT WAS IN USE WAS 381033 OR 381023. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO ITEM NUMBER, SAMPLE, BATCH, OR LOT CODE WAS PROVIDED. THIS COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED & TRENDED FOR FUTURE OCCURRENCES. THE COMPLAINT WAS DEEMED AS MDR REPORTABLE THEREFORE A SUBMISSION WILL BE PERFORMED. SHALL A SAMPLE OR LOT NUMBER BECOME AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND AN INVESTIGATION WILL TAKE PLACE. THIS COMPLAINT WILL BE CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER TIP OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER MAY HAVE "BROKE" AND REMAINED IN THE VEIN OF THE PATIENT. THE FOLLOWING WAS REPORTED, "PATIENT HOSPITALIZED ON (B)(6) 2018 AFTER PLACEMENT OF GAMMA CLAMP ((B)(6) 2018). ON (B)(6) 2018, THE PATIENT POSES AS ADOPTER, SUSPICION OF THROMBOSIS AND A PRESENCE OF CATHETER TIP IN THE VEIN, IN THE LEFT FOREARM WHERE THE CATHETER WAS PLACED. THROMBOSIS IS CONFIRMED BY ULTRASOUND WITH THE IMAGE OF WHAT COULD BE A CATHETER TIP. ACTUAL STATE OF THE PATIENT: SETTING UP OF ARIXTRA DURING 45 DAYS - 2,5MG PER DAY. FINALLY PATIENT DIED FROM THE CONSEQUENCES OF CLOSTRIDIUM COLITIS ON (B)(6) 2018."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER TIP OF A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER MAY HAVE BROKE AND REMAINED IN THE VEIN OF THE PATIENT. THE FOLLOWING WAS REPORTED, "PATIENT HOSPITALIZED ON (B)(6) 2018 AFTER PLACEMENT OF GAMMA CLAMP ((B)(6) 2018). ON (B)(6) 2018, THE PATIENT POSES AS A DOPTER, SUSPICION OF THROMBOSIS AND A PRESENCE OF CATHETER TIP IN THE VEIN, IN THE LEFT FOREARM WHERE THE CATHETER WAS PLACED. THROMBOSIS IS CONFIRMED BY ULTRASOUND WITH THE IMAGE OF WHAT COULD BE A CATHETER TIP. ACTUAL STATE OF THE PATIENT: SETTING UP OF ARIXTRA DURING 45 DAYS - 2.5MG PER DAY FINALLY PATIENT DIED FROM THE CONSEQUENCES OF CLOSTRIDIUM COLITIS ON (B)(6) 2018."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030769 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R