BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE VIALON 24GA X 0.75IN

    MDR report key: 20506561 · Received October 22, 2024

    Report

    Report Number
    2243072-2024-01062
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    August 11, 2024
    Report Date
    November 27, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903814121
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. PER THE DESCRIPTION, PARTICULATES WERE OBSERVED AFTER SOLUTION INFUSION THRU THE CATHETER FLUID PATH AND COLLECTED IN A GLASS VIAL SOLUTION. IT WAS SUSPECTED TO BE SILICONE OIL. IN THE MANUFACTURING PROCESS, SILICONE IS APPLIED ON THE OUTER SURFACE OF THE CATHETER NOT INSIDE THE CATHETER. CURRENT CONTROLS INCLUDE AN OUTGOING INSPECTION AND IN-PROCESS INSPECTION IN PLACE TO CHECK FOR FOREIGN MATTER.

    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

    MATERIAL#: 388412 BATCH#:1230243. IT WAS REPORTED BY THE CUSTOMER THAT INCOMPATIBILITY. PARTICULATES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ¿ PRODUCT NAME AND/OR CATALOG NUMBER: INSYTE CATHETER, BD 381412; LOT 1230243; EXP 2026-08 ( 381412. ¿ LOT NUMBER OR SERIAL NUMBER LOT 1230243; EXP 2026-08. ¿ ANY INJURIES AND/OR HARM? NO. ¿ WHAT IS THE ISSUE YOU EXPERIENCED? INCOMPATIBILITY. PARTICULATES. PRODUCT CONTAINS SILICONE OIL? IF YES, IS THE LUBRICANT IN THE FLUID PATH? ¿ IS THE ACTUAL SAMPLE OR SAMPLE REPRESENTATIVE AVAILABLE? (IF POSSIBLE, PLEASE SEND AFFECTED SAMPLE) YES. ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 11-AUG-2024. 3. CAN YOU PLEASE PROVIDE THE BD LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? PROVIDED LOT# 1230243 NOT FOUND REF 388412 LOT 1230243. 4. TOTAL NUMBER OF OCCURRENCES? 2. 5. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? NO IMAGES AVAILABLE. 6. WHETHER PARTICULATE FOUND IN FLUID PATH? SOLUTION INFUSION THRU THE CATHETER FLUID PATH AND COLLECTED IN GLASS VIAL. PARTICULATE OBSERVED IN SOLUTION COLLECTED IN VIAL. SUSPECT SILICONE OIL. ADDITIONAL INFO: PLEASE NOTE SILICONE IS APPLIED ON THE OUTER SURFACE OF THE CATHETER. THANK YOU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE VIALON 24GA X 0.75IN HAD FOREIGN MATTER IT WAS REPORTED BY THE CUSTOMER THAT INCOMPATIBILITY. PARTICULATES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ¿ PRODUCT NAME AND/OR CATALOG NUMBER: INSYTE CATHETER, BD 381412; LOT 1230243; EXP 2026-08 (381412 ¿ LOT NUMBER OR SERIAL NUMBER LOT 1230243; EXP 2026-08 ¿ ANY INJURIES AND/OR HARM? NO ¿ WHAT IS THE ISSUE YOU EXPERIENCED? INCOMPATIBILITY. PARTICULATES. PRODUCT CONTAINS SILICONE OIL? IF YES, IS THE LUBRICANT IN THE FLUID PATH? ¿ IS THE ACTUAL SAMPLE OR SAMPLE REPRESENTATIVE AVAILABLE? (IF POSSIBLE, PLEASE SEND AFFECTED SAMPLE) YES ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 11-AUG-2024 3. CAN YOU PLEASE PROVIDE THE BD LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? PROVIDED LOT# 1230243 NOT FOUND REF 388412 LOT 1230243 4. TOTAL NUMBER OF OCCURRENCES? 2 5. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? NO IMAGES AVAILABLE. 6. WHETHER PARTICULATE FOUND IN FLUID PATH? SOLUTION INFUSION THRU THE CATHETER FLUID PATH AND COLLECTED IN GLASS VIAL. PARTICULATE OBSERVED IN SOLUTION COLLECTED IN VIAL. SUSPECT SILICONE OIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958009 BD INSYTE VIALON 24GA X 0.75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 1230243 00382903814121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown