BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM)

    MDR report key: 8775546 · Received July 10, 2019

    Report

    Report Number
    1710034-2019-00739
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 24, 2019
    Report Date
    September 10, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835110
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE PROVIDED. BD RECEIVED ONE 24GA USED NEXIVA UNIT WITHIN AN OPEN PACKAGE FROM LOT: 9088631. THROUGH THE VISUAL/MICROSCOPIC EXAMINATION, THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING THEREFORE CONFIRMING THE REPORTED ISSUE. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, BD COULD NOT DETERMINE A ROOT CAUSE. PATIENT RESIDUE THAT WAS OBSERVED WITHIN THE CATHETER PART OF THE UNIT INDICATES THE NEEDLE AND CATHETER WERE CORRECTLY ASSEMBLED AT THE TIME OF USE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM) EXPERIENCED A HOLE IN THE CATHETER WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383511, BATCH NO: 9088631. EVENT DESCRIPTION STATES: WHEN STAFF ATTEMPT TO MANIPULATE THE CATHETER WHEN PLACING, THE STYLET PUNCTURES THE CATHETER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM) EXPERIENCED A HOLE IN THE CATHETER WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383511, BATCH NO: 9088631. EVENT DESCRIPTION STATES: WHEN STAFF ATTEMPT TO MANIPULATE THE CATHETER WHEN PLACING, THE STYLET PUNCTURES THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571145 BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM) INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9088631 30382903835110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other