BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9503473 · Received December 20, 2019

    Report

    Report Number
    1710034-2019-01348
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    December 4, 2019
    Report Date
    February 4, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE SAMPLE THAT WAS SENT TO OUR INVESTIGATION SITE UNDER FEDEX TRACKING (B)(4) HAS BEEN LOST. THE DHR FOR LOT NUMBER 9233236 HAS BEEN REVIEWED: ONE POTENTIALLY RELATED QUALITY NOTIFICATION WAS DISCLOSED: (B)(4). NO OTHER QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. AN INVESTIGATION COULD NOT BE PERFORMED SO THE COMPLAINT IS UNCONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 383536, BATCH NO.9233236. IT WAS REPORTED THAT BEFORE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM AN RN NEEDED 2 HANDS TO RETRACT THE NEEDLE OUT OF THE ASSEMBLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER ISSUE THIS MORNING, SAME LOT #, THE RN NEEDED 2 HANDS TO RETRACT THE NEEDLE OUT OF THE ASSEMBLY. THE ED NURSE AS ASSISTING ANOTHER DEPARTMENT (OUTPATIENT INFUSION) TO PLACE THE LINE AND WHILE SHE WAS THERE, SHE POLLED THE STAFF AND THEY SAID THEY HAVE HAD ISSUES WITH THE CATHETERS. I¿M EMAILING NURSE LEADERS IN THE DEPARTMENTS HERE THAT INSERT THE MOST LINES TO CONFIRM IF THEY ARE HAVING ISSUES, AND WILL ASK THEM TO SAVE ANY PACKAGING AND DEVICES THAT HAVE MALFUNCTIONED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 383536, BATCH NO.9233236. IT WAS REPORTED THAT BEFORE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM AN RN NEEDED 2 HANDS TO RETRACT THE NEEDLE OUT OF THE ASSEMBLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER ISSUE THIS MORNING, SAME LOT #, THE RN NEEDED 2 HANDS TO RETRACT THE NEEDLE OUT OF THE ASSEMBLY. THE ED NURSE AS ASSISTING ANOTHER DEPARTMENT (OUTPATIENT INFUSION) TO PLACE THE LINE AND WHILE SHE WAS THERE, SHE POLLED THE STAFF AND THEY SAID THEY HAVE HAD ISSUES WITH THE CATHETERS. I¿M EMAILING NURSE LEADERS IN THE DEPARTMENTS HERE THAT INSERT THE MOST LINES TO CONFIRM IF THEY ARE HAVING ISSUES, AND WILL ASK THEM TO SAVE ANY PACKAGING AND DEVICES THAT HAVE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302307 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383536 9233236 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other