BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9539363 · Received January 2, 2020

    Report

    Report Number
    1710034-2020-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    November 19, 2019
    Report Date
    February 28, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835325
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH DISPLAYING TUBING DAMAGE AS IT CLEARLY SHOWS THAT LEAKAGE IS OCCURRING. THE LEAKAGE APPEARS TO BE APPROXIMATELY AN INCH AWAY FROM THE ADAPTER ON THE UNIT. THE REPORTED ISSUE WAS CONFIRMED. ALTHOUGH YOUR REPORTED ISSUE WAS CONFIRMED, THE PHOTOGRAPH DID NOT PROVIDE SUFFICIENT EVIDENCE TO DETERMINE A DEFINITE ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: G.4. DATE RECEIVED BY MANUFACTURER: 2019-12-30.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS CRACKED AND LEAKED BLOOD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383532; BATCH NO: 9150815. IT WAS REPORTED THAT THE TUBING WAS CRACKED WHICH RESULTED IN BLOOD LEAKAGE. EVENT DESCRIPTION PER EMAIL STATES: I AM UNSURE OF WHO TO PASS THIS ALONG TOO, BUT ONE OF THE NEXIVA'S 22G CATH CATHETERS THAT WE PLACED TODAY HAD A CRACK IN THE TUBING. AS THE NURSE INSERTED THE CATHETER BLOOD CAME DOWN THE LINE, AND IT LEAKED OUT A CRACK ON THE SIDE,EXPOSING THE NURSE. I AM UNSURE IF ANYONE EXPERIENCED THIS. WE FLUSHED THE LINE BEFORE REMOVAL TO SHOW YOU THE CRACK. WE ARE ALSO PLACING A SAFETY REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS CRACKED AND LEAKED BLOOD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383532 BATCH NO: 9150815 IT WAS REPORTED THAT THE TUBING WAS CRACKED WHICH RESULTED IN BLOOD LEAKAGE. EVENT DESCRIPTION PER EMAIL STATES: I AM UNSURE OF WHO TO PASS THIS ALONG TOO, BUT ONE OF THE NEXIVA'S 22G CATH CATHETERS THAT WE PLACED TODAY HAD A CRACK IN THE TUBING. AS THE NURSE INSERTED THE CATHETER BLOOD CAME DOWN THE LINE, AND IT LEAKED OUT A CRACK ON THE SIDE,EXPOSING THE NURSE. I AM UNSURE IF ANYONE EXPERIENCED THIS. WE FLUSHED THE LINE BEFORE REMOVAL TO SHOW YOU THE CRACK. WE ARE ALSO PLACING A SAFETY REPORT.

    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 WAS CRACKED AND LEAKED BLOOD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383532, BATCH NO: 9150815. IT WAS REPORTED THAT THE TUBING WAS CRACKED WHICH RESULTED IN BLOOD LEAKAGE. EVENT DESCRIPTION PER EMAIL STATES: I AM UNSURE OF WHO TO PASS THIS ALONG TOO, BUT ONE OF THE NEXIVA'S 22G CATH CATHETERS THAT WE PLACED TODAY HAD A CRACK IN THE TUBING. AS THE NURSE INSERTED THE CATHETER BLOOD CAME DOWN THE LINE, AND IT LEAKED OUT A CRACK ON THE SIDE,EXPOSING THE NURSE. I AM UNSURE IF ANYONE EXPERIENCED THIS. WE FLUSHED THE LINE BEFORE REMOVAL TO SHOW YOU THE CRACK. WE ARE ALSO PLACING A SAFETY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4789 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383532 9150815 30382903835325

    Patients

    Seq Age Sex Outcome Treatment
    1 Other