BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 8073062 · Received November 15, 2018

    Report

    Report Number
    2245270-2018-00082
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 19, 2018
    Report Date
    March 25, 2019
    Manufacturer
    VYGON MFG
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURER, (B)(4) FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED ONE SAMPLE FOR THIS COMPLAINT WHICH WAS LEAKING AT THE JUNCTION OF CATHETER AND WING WHEN FLUSHING IT. THE CATHETER WAS OBSTRUCTED SO THAT IT CAN'T BE FLUSHED UNTIL ITS TIP. MICROSCOPIC EXAMINATION SHOWED THAT THE CATHETER WAS BROKEN NEARLY HALF THE WAY AT THE BOTTOM OF THE WING. A ROUGH UNEVEN SURFACE WAS VISIBLE DOING A MICROSCOPIC EXAMINATION OF THE BREAKAGE AREA (SEE PHOTO). THE CUSTOMER MENTIONED THAT THEY DO NOT USE ALCOHOL; HOWEVER, THEY DO USE CHLORAPREP® FOR PATIENTS OVER 28 WEEKS. IT SHOULD BE NOTED THAT CHLORAPREP® CONTAINS 70% ISOPROPYL ALCOHOL. IT IS ESSENTIAL TO LET DISINFECTANTS DRY COMPLETELY BEFORE THE CATHETER IS PLACED, AS ALCOHOL OR ORGANIC SOLVENTS CAN DAMAGE THE CATHETER MATERIAL. THE BATCH HISTORY RECORD WAS 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, AND VISUAL TESTS ARE CARRIED OUT. THIS IS THE FIRST COMPLAINT FOR BATCH 8023300 AND THE SECOND REGARDING A LEAKING CATHETER ON CODE 4G07125235. FURTHER INVESTIGATION COULD NOT BE COMPLETED TO DETERMINE WHETHER ROOT CAUSE WAS RELATED TO MANUFACTURING; THEREFORE, NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. VYGON HAS RECORDED THIS INCIDENT AND WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    THE PICC NURSE NOTICED THAT THE CATHETER WAS LEAKING / THE DRESSING WAS ALL WET. · THE PICC NURSE CHANGED THE DRESSING - THE NURSE CALLED THE PICC MANAGER A SECOND TIME BECAUSE IT WAS LEAKING AT THE SITE AGAIN, THE DRESSING WAS ALL WET A SECOND TIME. · AFTER THE LINE WAS DISCONNECTED- THE PICC MANAGER TOOK THE PICC AND GENTLY FLUSHED IT OVER A PAPER TOWEL[?]DEBBIE IDENTIFIED THE EXACT LOCATION OF THE LEAK. · THE LEAK WAS RIGHT AT OR NEAR THE WING AREA ON THE CATHETER; NEAR WHERE THE CATHETER MEETS THE WINGS; THIS IS WHERE IT WAS LEAKING.

    Additional Manufacturer Narrative · 1

    THE MALFUNCTIONING CATHETER WAS RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Description of Event or Problem · 1

    THE PICC NURSE NOTICED THAT THE CATHETER WAS LEAKING / THE DRESSING WAS ALL WET. THE PICC NURSE CHANGED THE DRESSING - THE NURSE CALLED THE PICC MANAGER A SECOND TIME BECAUSE IT WAS LEAKING AT THE SITE AGAIN, THE DRESSING WAS ALL WET A SECOND TIME. AFTER THE LINE WAS DISCONNECTED- THE PICC MANAGER TOOK THE PICC AND GENTLY FLUSHED IT OVER A PAPER TOWEL (B)(6) IDENTIFIED THE EXACT LOCATION OF THE LEAK. THE LEAK WAS RIGHT AT OR NEAR THE WING AREA ON THE CATHETER; NEAR WHERE THE CATHETER MEETS THE WINGS; THIS IS WHERE IT WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915263 NUTRILINE LONG TERM INTRAVASCULAR CATHETER LJS VYGON MFG 1252.35G 17L042D

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DA