BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 20 GA X 1 IN SINGLE PORT

    MDR report key: 19934153 · Received August 7, 2024

    Report

    Report Number
    1710034-2024-00846
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835164
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE CATHETER WAS PUNCTURED BY THE NEEDLE WAS CONFIRMED AND THE CAUSE APPEARED TO BE ASSOCIATED WITH USE. ONE 20G NEXIVA DEVICE WAS PROVIDED FOR INVESTIGATION. THE RETURNED SAMPLE EXHIBITED EVIDENCE OF USE. THE NEEDLE WAS PROTRUDING THROUGH THE IV CATHETER TUBING AND THE SECTION OF TUBING BETWEEN THE CATHETER TIP AND NEEDLE CONTAINED WHAT APPEARED TO BE BLOOD RESIDUE, WHICH SUGGESTED THAT THE DAMAGE LIKELY OCCURRED DURING USE. THE INSTRUCTIONS FOR USE (IFU) WARN THAT IF THE NEEDLE IS PARTIALLY OR COMPLETELY WITHDRAWN FROM THE CATHETER TUBING DURING INSERTION, DO NOT RE-INSERT THE NEEDLE INTO THE CATHETER TUBING AS DAMAGE MAY OCCUR. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO ISSUES WITH THE MANUFACTURING PROCESS. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS TYPE OF FAILURE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL #: 383516 BATCH #: 4030903 IT WAS REPORTED THAT THE BD NEXIVA 20 GA X 1 IN SINGLE PORT NEEDLE WENT THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CATH IV NEEDLE NEXIVA 20GA X 1IN, MNFG IS 383516 LOT #4030903 I HAVE PICTURES, PENDING CONFIRMATION IF I HAVE THE ACTUAL CATHETER TO SEND BACK FOR YOUR REVIEW. RIGHT AFTER INSERTION THE CATHETER BEGAN LEAKING, IV WAS REMOVED (NEEDLE WAS STILL IN); THE NEEDLE HAD POKED THROUGH THE BOTTOM OF CATHETER. NEW IV PLACED. ADDITIONAL INFORMATION PROVIDED: 1. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? IF YES, DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. YES, IV HAD TO BE RESTARTED. 2. PLEASE SHARE THE AVAILABLE PHOTOS FOR INVESTIGATION. KINDLY CONFIRM IS THERE ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION. YES, WE DO HAVE THE SAMPLE THAT CAN BE RETURNED FOR REVIEW. 3. IF PHYSICAL SAMPLE AVAILABLE KINDLY SHARE THE EXACT ADDRESS TO SEND A RETURN SHIPPING LABEL? (B)(6). 4. CAN YOU PROVIDE AN EVENT DATE? 7/9/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574009 BD NEXIVA 20 GA X 1 IN SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030903 00382903835164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown