BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ SINGLE PORT CATHETER

    MDR report key: 13831203 · Received March 20, 2022

    Report

    Report Number
    1710034-2022-00132
    Event Type
    Malfunction
    Date Received
    March 20, 2022
    Date of Event
    February 25, 2022
    Report Date
    April 18, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835202
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 01-APR-2022. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNOPENED UNIT FROM LOT NUMBER 1133184. A VISUAL INSPECTION OF THE EXTENSION TUBING WAS PERFORMED UNDER MAGNIFICATION. NO DAMAGE TO THE EXTENSION TUBING WAS IDENTIFIED. A LEAK TEST WAS PERFORMED WHERE LEAKAGE WAS NOT OBSERVED. THE RETURNED UNIT PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE CONNECTION POINT OF THE BD NEXIVA¿ SINGLE PORT CATHETER FLEXURE TUBE WHILE ADMINISTERING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "DURING THE ADMINISTRATION OF FOREIGN BLOOD (EC), LEAKAGE OCCURRED AT THE CONNECTION POINT OF THE FLEXURE TUBE. THE BLOOD PRODUCT WAS CONNECTED TO THE CONNECTION PORT. THE BLOOD HAS LEAKED AT THE POINT WHERE THE CONNECTION PORT ENDS IN THE "WINGS" OF THE FLEXURE TUBE. THE FLEXURE PATCH WAS FOUND TO BE NEW AND UNCONTAMINATED. THE PLASTER WAS ALSO CONTAMINATED WITH BLOOD AT THE SAME RATE AS THE BLOOD WAS DRIPPING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE CONNECTION POINT OF THE BD NEXIVA¿ SINGLE PORT CATHETER FLEXURE TUBE WHILE ADMINISTERING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "DURING THE ADMINISTRATION OF FOREIGN BLOOD (EC), LEAKAGE OCCURRED AT THE CONNECTION POINT OF THE FLEXURE TUBE. THE BLOOD PRODUCT WAS CONNECTED TO THE CONNECTION PORT. THE BLOOD HAS LEAKED AT THE POINT WHERE THE CONNECTION PORT ENDS IN THE "WINGS" OF THE FLEXURE TUBE. THE FLEXURE PATCH WAS FOUND TO BE NEW AND UNCONTAMINATED. THE PLASTER WAS ALSO CONTAMINATED WITH BLOOD AT THE SAME RATE AS THE BLOOD WAS DRIPPING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544446 BD NEXIVA¿ SINGLE PORT CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383520 1133184 30382903835202

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown