BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8549349 · Received April 25, 2019

    Report

    Report Number
    1710034-2019-00445
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 1, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835110
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED 17 NEXIVA UNUSED UNITS WITHIN A DISPENSER AND IN SEALED PACKAGES FROM LOT NUMBER 8235512. ALL CONTENTS WITHIN WERE INTACT. THROUGH THE VISUAL/MICROSCOPIC EVALUATION THE EXTENSION TUBINGS WERE MANUALLY PULLED ON ALL UNITS RECEIVED. THE EXTENSION TUBING OF 2 OF THE UNITS RECEIVED DISCONNECTED WHEN PULLED. THERE WERE NO TRACES OF ADHESIVE PRESENT ON THESE EXTENSION TUBINGS. NO DISCONNECTIONS OCCURRED ON THE REST OF THE UNITS RECEIVED. THE REPORTED ISSUE WAS CONFIRMED AS THERE WAS NOT SUFFICIENT ADHESIVE IN THE EXTENSION TUBING/ ADAPTER JOINT. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO AN INSUFFICIENT AMOUNT OF ADHESIVE DISPENSED IN THE TUBING/ADAPTER PORT JOINT. CORRECTIVE ACTIONS HAVE BEEN INITIATED TO MONITOR THE REPORTED ISSUE. CAPA#(B)(4) WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBING FELL OFF. THIS OCCURRED ON 2 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511, BATCH NO.: 8235512. IT WAS REPORTED THAT THE IV TUBING FELL OFF ABOUT WHERE THE FLASHBACK HAPPENS. PER (B)(4) VERBATIM: HEALTH PROFESSIONAL CALLED TO REPORT THAT THE IV TUBING FELL OFF ON 2 SETS ABOUT WHERE THE FLASHBACK HAPPENS. UNUSED PRODUCT IS AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 FELL OFF. THIS OCCURRED ON 2 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511, BATCH NO.: 8235512. IT WAS REPORTED THAT THE IV TUBING FELL OFF ABOUT WHERE THE FLASHBACK HAPPENS. PER (B)(4) VERBATIM: HEALTH PROFESSIONAL CALLED TO REPORT THAT THE IV TUBING FELL OFF ON 2 SETS ABOUT WHERE THE FLASHBACK HAPPENS. UNUSED PRODUCT IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343492 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8235512 30382903835110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other