BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4F SINGLE MIDLINE MAX BARRIER KIT

    MDR report key: 14635398 · Received June 8, 2022

    Report

    Report Number
    2245270-2022-00037
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 27, 2022
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K172899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE THREE (3) OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: 2245270-2022-00036. 2245270-2022-00038. ALTHOUGH NO DEVICE WAS RETURNED FOR EVALUATION, THE DETAILS OF THE MALFUNCTION WILL BE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 0

    THERE WERE THREE (3) OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: 2245270-2022-00036. 2245270-2022-00038. THE SUPPLIER WAS CONTACTED FOR AN INVESTIGATION AND RESPONSE. THE RESPONSE IS AS FOLLOWS: WE PURCHASED ((B)(4)) UNITS OF DSS-010-045 (PRCGM038862) AND (PRCGM038863) FROM APPROVED SUPPLIER; HOWEVER ((B)(4)) UNITS SHIPPED TO VYGON US AND THE REMAINDER UNITS SHIPPED TO OTHER CUSTOMERS. VYGON US HAD TWO COMPLAINTS FOR THE PRODUCT, SATURATION LEVEL FOR THE OCCURRENCE IS 0.1%. WE DID NOT RECEIVE ANY COMPLAINT FOR THE REMAINDER UNITS THAT HAVE BEEN SHIPPED TO OTHER CUSTOMERS; THEREFORE, OVERALL SATURATION LEVEL IS 0.08%. NO ADVERSE EVENT OCCURRED ACCORDING TO THE CUSTOMER. DHRS HAS BEEN REVIEWED FOR MAIN PRODUCT AND SUBCOMPONENTS; THERE WAS NO ABNORMALITY OR NONCONFORMANCE RECORDED. ALL PARTS MANUFACTURED ACCORDING TO INTERNAL DRAWINGS. THE CUSTOMER WAS NOT ABLE TO PROVIDE A PHOTO FOR THE COMPLAINT AND THE END USER DISCARDED THE SAMPLE; THEREFORE, INVESTIGATION CONDUCTED PER DHRS REVIEW. INVESTIGATION PER DHR SHOWS THAT THERE WERE NO ABNORMALITY OR DISCREPANCY DURING MANUFACTURING PROCESS. WE CAN'T PERFORM EVALUATION WITHOUT COMPLAINT SAMPLE, THIS COMPLAINT CAN'T BE CONFIRMED. DEVICE HISTORY RECORD SHOWS THAT ALL PROCESSES WERE PERFORMED AS SPECIFIED. DEVICE HISTORY RECORD SHOWS THAT ALL EQUIPMENT AND MATERIAL USED ARE AS SPECIFIED. NO INCIDENTS RECORDED AT TIME OF MANUFACTURE. A REVIEW OF VYGON'S COMPLAINTS SHOWED THIS IS THE SECOND ISSUE WITH THE INTRODUCER PEELING ASSOCIATED WITH THIS PRODUCT CODE OVER THE PAST TWO YEARS. CORRECTIVE ACTION: DUE TO THE MISSING SAMPLE, THE ROOT CAUSE OF THIS ISSUE COULD NOT BE CONFIRMED. THEREFORE, NO CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. THIS FAILURE WILL BE MONITORED FOR FUTURE ACTIONS.

    Description of Event or Problem · 0

    THE INTRODUCER GETS CAUGHT ON THE SKIN OR VEIN WALL AND BUNCHES LIKE "AND" ACCORDION. OR THE EDGE OF THE INTRODUCER STARTS TO PEEL BACK LIKE A BANANA.

    Description of Event or Problem · 0

    THE INTRODUCER GETS CAUGHT ON THE SKIN OR VEIN WALL AND BUNCHES LIKE AND ACCORDION. OR THE EDGE OF THE INTRODUCER STARTS TO PEEL BACK LIKE A BANANA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27381 4F SINGLE MIDLINE MAX BARRIER KIT LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA VYML4S3001S 21G033D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown