BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 14810141 · Received June 24, 2022

    Report

    Report Number
    1710034-2022-00315
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 12, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835110
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES. RETURNED TO MANUFACTURER ON: 15-JUN-2022. INVESTIGATION SUMMARY BD RECEIVED AN UNSEALED 24 GAUGE NEXIVA SINGLE PORT DEVICE FROM LOT 2091312 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED DAMAGE TO THE CLAMP AND EXTENSION TUBING, BUT THERE WAS NO DAMAGE TO THE BACK OF THE ADAPTER. A PHOTO WAS ALSO PROVIDED WHICH SHOWED DAMAGE TO THE NEEDLE HUB VERIFYING THE REPORTED DEFECT. DURING MANUFACTURING, A CRACKED ADAPTER MAY OCCUR DURING THE ASSEMBLY PROCESS ANYWHERE THE ADAPTER ENCOUNTERS GRIPPERS. THIS WAS GENERALLY DUE TO A MISALIGNMENT AND/OR INCORRECT GRIPPER SETTINGS. SETUP VERIFICATION AND SAMPLING WAS PERFORMED BY ASSEMBLY OPERATORS. UNFORTUNATELY, THE PHYSICAL SAMPLE DID NOT SHOW EVIDENCE OF THIS DEFECT SO THE ENGINEER COULD NOT CONFIRM IF THIS WAS THE CASE OR IDENTIFY A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM, EXPERIENCE DIFFICULT NEEDLE DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AN INCIDENT WAS REPORTED HERE, CATHETER WAS USED, NO HARM TO THE PATIENT. LOT # 2091312. THE NEEDLE WOULD NOT DISCONNECT FROM THE CATHETER. RN USED THE PRODUCT FOR CHEMO AND I WAS ABLE TO SEPARATE AFTER THE FACT AND IT LOOKS LIKE THE BACK OF THE CATHETER HOUSING IS DAMAGED. PLEASE LET ME KNOW IF YOU WOULD LIKE ME TO SEND THE DAMAGED PRODUCT BUT PLEASE KEEP IN MIND THAT IT HAS BEEN USED FOR CHEMO AND MAY CONTAIN HAZARDOUS MATERIAL."

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM, EXPERIENCE DIFFICULT NEEDLE DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AN INCIDENT WAS REPORTED HERE, CATHETER WAS USED, NO HARM TO THE PATIENT. LOT # 2091312. THE NEEDLE WOULD NOT DISCONNECT FROM THE CATHETER. RN USED THE PRODUCT FOR CHEMO AND I WAS ABLE TO SEPARATE AFTER THE FACT AND IT LOOKS LIKE THE BACK OF THE CATHETER HOUSING IS DAMAGED. PLEASE LET ME KNOW IF YOU WOULD LIKE ME TO SEND THE DAMAGED PRODUCT BUT PLEASE KEEP IN MIND THAT IT HAS BEEN USED FOR CHEMO AND MAY CONTAIN HAZARDOUS MATERIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055017 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383511 2091312 30382903835110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown