BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8632765 · Received May 22, 2019

    Report

    Report Number
    1710034-2019-00540
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    April 17, 2019
    Report Date
    August 8, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: PROTOCOL # PMA/510(K)#: K183399.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED SAMPLE PROVIDED BY YOUR FACILITY. BD RECEIVED ONE USED NEXIVA 18GA UNIT WITHOUT PACKAGING FROM CATALOG NUMBER 383519; LOT NUMBER 8093534. THROUGH THE VISUAL MICROSCOPIC EVALUATION, THE EXTENSION TUBING WAS OBSERVED TO BE SPLIT AT THE CLEAR PORT OF THE WINGED ADAPTER. THE REPORTED ISSUE WAS CONFIRMED. ALTHOUGH THE REPORTED DEFECT WAS CONFIRMED WITH THE RETURNED USED UNIT, THERE WAS NOT ENOUGH PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: DATE OF EVENT: (B)(6) 2019.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBING LINE BLEW OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 383519 BATCH NO. 8093534. IT WAS REPORTED THAT THE TUBING LINE BLEW OUT. "I HAVE A NEXIVA SET, #383519, LOT #8093534, THAT FAILED. THE TUBING LINE BLEW OUT JUST BEFORE THE "Y" PORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBING LINE BLEW OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 383519 BATCH NO. 8093534. IT WAS REPORTED THAT THE TUBING LINE BLEW OUT. "I HAVE A NEXIVA SET, #383519, LOT #8093534, THAT FAILED. THE TUBING LINE BLEW OUT JUST BEFORE THE "Y" PORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBING LINE BLEW OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 383519 BATCH NO. 8093534. IT WAS REPORTED THAT THE TUBING LINE BLEW OUT. "I HAVE A NEXIVA SET, #383519, LOT #8093534, THAT FAILED. THE TUBING LINE BLEW OUT JUST BEFORE THE "Y" PORT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 TUBING LINE BLEW OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(4). IT WAS REPORTED THAT THE TUBING LINE BLEW OUT. "I HAVE A NEXIVA SET, #383519, LOT #8093534, THAT FAILED. THE TUBING LINE BLEW OUT JUST BEFORE THE "Y" PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428189 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8093534 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other