BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9632672 · Received January 27, 2020

    Report

    Report Number
    1710034-2020-00024
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    January 4, 2020
    Report Date
    February 28, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF TUBING DEFECTIVE / DAMAGED WITH LOT #9241111 REGARDING ITEM #383536. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD A HOLE AND LEAKED BLOOD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383536 BATCH NO.: 9241111 IT WAS REPORTED THAT THERE WAS A HOLE IN THE TUBING AROUND THE CLAMP WHICH CAUSED SIGNIFICANT BLOOD LEAKAGE. I HAVE HAD A COUPLE OF IVS. THE SECOND ONE THEY PUT IN I BLED OUT SIGNIFICANTLY. TURNS OUT THERE WAS A HOLE IN THE TUBING AROUND THE CLAMP ON THE SALINE LOCK PORTION. WAS A MESS. THEY TOOK THAT ONE OUT AND PUT A NEW ONE IN. THEY SAID THEY WOULD REPORT IT TOO BUT I THOUGHT I SHOULD SEND IT TO YOU AS WELL.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD A HOLE AND LEAKED BLOOD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383536, BATCH NO.: 9241111. IT WAS REPORTED THAT THERE WAS A HOLE IN THE TUBING AROUND THE CLAMP WHICH CAUSED SIGNIFICANT BLOOD LEAKAGE. I HAVE HAD A COUPLE OF IVS. THE SECOND ONE THEY PUT IN I BLED OUT SIGNIFICANTLY. TURNS OUT THERE WAS A HOLE IN THE TUBING AROUND THE CLAMP ON THE SALINE LOCK PORTION. WAS A MESS. THEY TOOK THAT ONE OUT AND PUT A NEW ONE IN. THEY SAID THEY WOULD REPORT IT TOO BUT I THOUGHT I SHOULD SEND IT TO YOU AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98398 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383536 9241111 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other