BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9748265 · Received February 24, 2020

    Report

    Report Number
    1710034-2020-00113
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    January 13, 2020
    Report Date
    March 31, 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
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED A 22GA NEXIVA IV CATHETER SYSTEM DUAL PORT UNIT WITHOUT PACKAGING. THE UNIT CONSISTS OF THE DUAL PORT ADAPTER THAT HAS A PORTION OF EXTENSION LINE INTACT AND A Q-SYTE ATTACHED TO THE LUER OF EACH PORT. THE PHOTO REVEALS THAT THE EXTENSION TUBING IS NOT THE FULL LENGTH AS MANUFACTURED AND HAS A CLEAR FLUID PRESENT. THE PHOTO ALSO REVEALS THAT A CUT OR BREAK TO THE EXTENSION TUBING MOST LIKELY OCCURRED, WHICH IS BASED ON THE SEEN LENGTH OF THE TUBING IN THE PHOTO. THE PHOTO DID NOT PROVIDE SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. EXAMINATION OF THE ACTUAL 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 THESE BATCHES. 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 ADAPTER SEPARATED FROM THE TUBING. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CANNULA WAS BEING USED AND EXTENSION SET CAME OUT. UNABLE TO ASCERTAIN EXACTLY WHICH OF THE LOT NUMBERS WAS EFFECTED AS PACKAGING HAD ALREADY BEEN THROWN OUT.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9233253. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2019-08-21. MEDICAL DEVICE LOT #: 9233261. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2019-08-21. MEDICAL DEVICE LOT #: 9200518. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2019-07-19. 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 ADAPTER SEPARATED FROM THE TUBING. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CANNULA WAS BEING USED AND EXTENSION SET CAME OUT. UNABLE TO ASCERTAIN EXACTLY WHICH OF THE LOT NUMBERS WAS EFFECTED AS PACKAGING HAD ALREADY BEEN THROWN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211644 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383532 SEE H.10 30382903835325

    Patients

    Seq Age Sex Outcome Treatment
    1 Other