BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9186121 · Received October 14, 2019

    Report

    Report Number
    1710034-2019-01103
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 27, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835394
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WERE NO SAMPLES OR PHOTOS AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM NEEDLE WAS DIFFICULT TO DISENGAGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383539 BATCH NO.: 9162759. IT WAS REPORTED THAT THE NEEDLE WOULD NOT COME OUT OF THE CATHETER UNTIL AFTER SEVERAL ATTEMPTS AND PULLING. PER MED WATCH: WHEN STARTING IV THE NEXIVA CATHETER DID NOT COME APART FROM THE CATHETER AS NORMAL. 2 OTHER RNS ENTERED THE ROOM & AFTER SOME ATTEMPTS AT WIGGLES & PULLING AT NEEDLE, THEY FINALLY WERE ABLE TO GET THE 2 PIECES OFF.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 30 SEPTEMBER, 2019. MEDWATCH REPORT # (B)(4). REPORT SOURCE OTHER: MEDWATCH REPORT. 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 NEEDLE WAS DIFFICULT TO DISENGAGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383539. BATCH NO.: 9162759. IT WAS REPORTED THAT THE NEEDLE WOULD NOT COME OUT OF THE CATHETER UNTIL AFTER SEVERAL ATTEMPTS AND PULLING. PER MED WATCH: WHEN STARTING IV THE NEXIVA CATHETER DID NOT COME APART FROM THE CATHETER AS NORMAL. 2 OTHER RNS ENTERED THE ROOM & AFTER SOME ATTEMPTS AT WIGGLES & PULLING AT NEEDLE, THEY FINALLY WERE ABLE TO GET THE 2 PIECES OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983521 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9162759 30382903835394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other