BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 10269525 · Received July 14, 2020

    Report

    Report Number
    1710034-2020-00445
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 17, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835127
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A 22 GAUGE NEXIVA SINGLE PORT UNIT FROM LOT 8361792 FOR EVALUATION ALONG WITH THREE PHOTOS OF THE DEFECT. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE TIP SHIELD HAD BEEN ENGAGED BUT WOULD NOT SEPARATED FROM THE WINGED ADAPTER. EXCESSIVE FORCE HAD TO BE USED TO CAUSE THE TWO COMPONENTS TO SEPARATE AND ONCE THEY DID A POPPING SOUND WAS HEARD. THE TIP SHIELD WAS THEN INSPECTED AND DAMAGE WAS FOUND TO THE INSIDE PLASTIC AND ADHESIVE WAS FOUND ON THE BARREL. IT WAS DETERMINED THAT THIS ADHESIVE CAUSED THE TWO UNITS TO STICK TOGETHER PREVENTING RETRACTION. SIMILAR FINDINGS WERE FOUND WITH THE PROVIDED PHOTOS. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT ADHESIVE CAME FROM A IMPROPER PLACEMENT OR EXCESSIVE BUILD UP OF ADHESIVE DURING THE ASSEMBLY PROCESS. DHR WAS REVIEWED. ONE RELATED TEMPORARY DEVIATION WAS FOUND (2018-63).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM PUSH-TAB WOULD NOT RELEASE TO RETRACT THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "AFTER PUNCTURE, HCP TRIED TO WITHDRAW THE NEEDLE BUT WAS UNABLE TO RELEASE THE PUSH-TAB, RESULTING IN A FAILURE OF CATHETER PLACEMENT."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM PUSH-TAB WOULD NOT RELEASE TO RETRACT THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AFTER PUNCTURE, HCP TRIED TO WITHDRAW THE NEEDLE BUT WAS UNABLE TO RELEASE THE PUSH-TAB, RESULTING IN A FAILURE OF CATHETER PLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733075 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383512 8361792 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other