BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 7845752 · Received September 5, 2018

    Report

    Report Number
    2245270-2018-00059
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 15, 2018
    Report Date
    November 1, 2018
    Manufacturer
    VYGON MFG
    Product Code
    LJS
    PMA / PMN Number
    K052475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN (B)(6) FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: THIS COMPLAINT CANNOT BE CLASSIFIED AS NO SAMPLE HAD BEEN RETURNED. THIS COMPLAINT COULD NOT BE INVESTIGATED AS WE DID NOT RECEIVE A SAMPLE FOR EXAMINATION. THE BATCH HISTORY RECORDS WERE REVIEWED AND DID NOT SHOW ANY DEVIATIONS DURING THE PRODUCTION. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. VISUAL TESTS ARE PERFORMED AS WELL. THIS IS THE 4TH COMPLAINT FOR BATCH 8001914 AND THE 3RD FOR BATCH 8002182. CONCERNING A LEAKING CODE (B)(4) THIS IS THE 11TH COMPLAINT - BUT NONE OF THEM HAVE FOUND TO BE MANUFACTURING RELATED. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. HOWEVER, BOTH (B)(4) AND VYGON USA WILL ENTER THIS INCIDENT INTO OUR COMPLAINT LOG AND CONTINUE MONITORING FOR THIS PROBLEM.

    Description of Event or Problem · 0

    CATHETER IN PLACE FOR 5-6 WEEKS THEN IT STARTED LEAKING JUST DISTAL TO THE FIXATION WINGS. THEY REPLACED THIS WITH A TWINFLO SAME LOT NUMBER, HAD NO FURTHER ISSUES.

    Additional Manufacturer Narrative · 1

    .THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITH IN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOWUP MDR

    Description of Event or Problem · 1

    CATHETER IN PLACE FOR 5-6 WEEKS THEN IT STARTED LEAKING JUST DISTAL TO THE FIXATION WINGS. THEY REPLACED THIS WITH A TWINFLO SAME LOT NUMBER, HAD NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687143 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON MFG 1252.232G 17A034D

    Patients

    Seq Age Sex Outcome Treatment
    1