BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRILINE

    MDR report key: 21200981 · Received January 21, 2025

    Report

    Report Number
    2245270-2025-00003
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    October 12, 2024
    Report Date
    January 21, 2025
    Manufacturer
    VYGONGMBH
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN ADDITION TO A FAULTY SAMPLE THE CUSTOMER PROVIDED AN IMAGE, SHOWING THAT THE CATHETER WAS USED FOR INFUSION WITH THE STYLET STILL INSIDE THE CATHETER. WE RECEIVED A PART OF THE STYLET WITH A LENGTH OF APPROX. 13.3 CM AS FAULTY SAMPLE. THE MICROSCOPIC EXAMINATION OF THE STYLET SURFACE SHOWED MECHANICAL DAMAGES INSIDE THE GREEN COATING. THE ROUGH TIP OF THE STYLET INDICATES THAT THE STYLET WAS TORN OUT. UNFORTUNATELY, THE CUSTOMER DID NOT PROVIDE THE REMAINING STYLET WITH Y-PIECE, WHICH WOULD HAVE PROVIDED MORE INFORMATION ON THE PROBLEM AND THE ROOT CAUSE. THE DESCRIPTION OF OUR FRENCH COLLEAGUE AS WELL AS THE PICTURE PROVIDED FROM THE CUSTOMER INDICATE A SERVE USER FAULT. THE INSTRUCTIONS FOR USE CLEARLY STATE THAT THE STYLET MUST BE REMOVED. REGARDING THE PRODUCT INSTRUCTION THE FOLLOWING IS RECOMMENDED: "IF DIFFICULTY IS EXPERIENCED REMOVING THE STYLET STOP, LET VEIN REST FOR A MINUTE AND TRY REMOVAL AGAIN VERY SLOWLY. GENTLE FLUSHING OF THE CATHETER WITH DILUTED LIPID SOLUTION (PREFERRED) OR SALINE ASSISTS IN STYLET REMOVAL. IF RESISTANCE STILL REMAINS, WITHDRAW CATHETER AND STYLET SIMULTANEOUSLY. HAVING CHECKED THE BATCH HISTORY RECORDS; NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED WITH ITS SPECIFICATION AND WAS RELEASED. THE TENSILE FORCE AND DIMENSIONS OF CATHETER AND SET COMPONENTS ARE RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS AFTER PACKAGING ARE CARRIED OUT. TWO BATCHES WERE USED FOR THE ASSEMBLY GROUP OF THE STYLET (INVOLVED CODE 7G12565010). THE VALUE OF THE TENSILE FORCE OF THE STYLET FOR BATCH 0400946001 WAS MIN. 10.89 N AND FOR BATCH 0414263001 MIN. 10.60 N. THEREFORE, BOTH BATCHES WERE WITHIN THEIR SPECIFICATION (MIN. 9 N). THREE DIFFERENT BATCHES WERE USED FOR THE ASSEMBLY GROUP OF THE CONNECTION BETWEEN STYLET AND Y-PIECE (INVOLVED CODE 4G31252030). THE VALUE OF THE TENSILE FORCE OF THE CONNECTION FOR BATCH 8241395 WAS 5.94 N, FOR BATCH 8243787 5.79 N AND FOR BATCH 8248014 6.87 N. THEREFORE, ALL BATCHES WERE WITHIN THEIR SPECIFICATION (MIN. 3.1 N - MAX. 9 N). IT IS A SAFETY FEATURE THAT THE TENSILE STRENGTH OF THE STYLET EXCEEDS THE TENSILE STRENGTH OF THE CONNECTION BETWEEN THE STYLET AND THE Y-PIECE TO ENSURE THAT THE STYLET DO NOT SNAP INTO ITSELF. THERE IS NO FURTHER COMPLAINT FOR BATCH 140624GS, BUT SEVEN FURTHER COMPLAINTS REGARDING A PROBLEM WITH A TORN OUT OR SNAPPED STYLET ON CODE 1252.030 WITHIN THE LAST THREE YEARS. THIS QUERY RELATES TO ALL COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AS THERE IS NO HINT OF A MANUFACTURING FAULT. THUS, AS VYGON, WE DO NOT TAKE RESPONSIBILITY FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    PLACED ON (B)(6) 2024 (LOWER G LIMB MARKS 24 CM) IN (B)(6) (N FULL TERM CARDIOPATHY). GUIDE LEFT BY MISTAKE IN THE KT. INFUSION OF NUTRITION SOLUTION ON THE KT. (B)(6): TRANSFER TO THE (B)(6). COLLECTION OF THE GUIDE UPON ARRIVAL BY THE (B)(6) TEAM: POSSIBLE/PROBABLE SECTION AT THAT TIME. 13 CM OF GUIDE FOUND A FEW DAYS LATER INTRACARDIAC, "BY CHANCE", DURING PLANNED CARDIAC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630032 NUTRILINE INTRAVASCULAR CATHETER LJS VYGONGMBH 1252.030 140624GS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention