BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER

    MDR report key: 16510538 · Received March 9, 2023

    Report

    Report Number
    1710034-2023-00207
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 10, 2023
    Report Date
    April 5, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835577
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER PHONE #: (B)(6).

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO PHOTOS OR SAMPLES DISPLAYING THE REPORTED CONDITION OF ADAPTER / CONNECTOR MISSING WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. DEVICE HISTORY RECORD REVIEW IT WAS DETERMINED THAT THE PRODUCT REPORTED IS PAST ITS EXPIRATION DATE OF 31-MAY-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER TUBING CLAMP WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 19042, (B)(6) 2019, FHA DH OR LOW IV CATH NEXIVA SP AND MZ 20GX 1.25IN PV 0.5 ML FR 58 ML MIN PINK W/MAXZERO, 469024, 383557, BD 9143739- 308-383557, 1 PARTS MISSING/INCORRECT MISSING CLAMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER TUBING CLAMP WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 19042 13-DEC-2019 FHA DH OR LOW IV CATH NEXIVA SP AND MZ 20GX 1.25IN PV 0.5 ML FR 58 ML MIN PINK W/MAXZERO 469024 383557 BD 9143739- 308-383557 1 PARTS MISSING/INCORRECT MISSING CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629603 BD NEXIVA¿ CLOSED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9143739 00382903835577

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown