BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM)

    MDR report key: 8729009 · Received June 24, 2019

    Report

    Report Number
    1710034-2019-00660
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    May 31, 2019
    Report Date
    August 23, 2019
    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
    CT, US
    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. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM) EXPERIENCED CATHETER SPLITTING/CRACKING/FRAYING, AND THE CATHETER BROKE/SEPARATED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383532 BATCH NO.: 9050711. PER EMAIL: REPORTED ISSUE: THE CATHETER TUBING SURROUNDING 2 OF THE NEEDLES SPLIT OPEN. PER PHONE CALL: THE INCIDENT OCCURRED ON (B)(6) 2019. THE CATHETER SPLIT OPEN CAUSING IT TO SEPARATE FROM THE NEEDLE, LEAVING THE CATHETER IN THE PATIENT'S ARM AT AN ANGLE. IT HAD TO BE REMOVED AND REPLACED WITH A NEW ONE. THEY HAVE DISPOSED OF THE CATHETER AS THEY WERE NOT COMFORTABLE SHIPPING IT WITH BLOOD ON IT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM) EXPERIENCED CATHETER SPLITTING/CRACKING/FRAYING, AND THE CATHETER BROKE/SEPARATED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383532, BATCH NO.: 9050711. PER EMAIL: REPORTED ISSUE: THE CATHETER TUBING SURROUNDING 2 OF THE NEEDLES SPLIT OPEN. PER PHONE CALL: THE INCIDENT OCCURRED ON (B)(6) 2019. THE CATHETER SPLIT OPEN CAUSING IT TO SEPARATE FROM THE NEEDLE, LEAVING THE CATHETER IN THE PATIENT'S ARM AT AN ANGLE. IT HAD TO BE REMOVED AND REPLACED WITH A NEW ONE. THEY HAVE DISPOSED OF THE CATHETER AS THEY WERE NOT COMFORTABLE SHIPPING IT WITH BLOOD ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523234 BD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM) INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9050711 30382903835325

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other