BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 12672472 · Received October 21, 2021

    Report

    Report Number
    2245270-2021-00111
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 27, 2021
    Report Date
    December 17, 2021
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K052475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WE'VE RECEIVED THE CATHETER AS A SAMPLE. BOTH LL-HUBS ARE CONNECTED TO A NEEDLE FREE CONNECTION SYSTEM. IN ADDITION, INFUSION/MEDICATION RESIDUES ARE VISIBLE ON THE CATHETER AND THE EXTENSION LINE. FLUSHING THE ORANGE LUMEN DOES NOT RESULT IN A FLOW BECAUSE IT IS OCCLUDED. FLUSHING OF THE GREEN LUMEN RESULTS IN FLOW BUT ALSO SHOWS LEAKAGE IN THE BUMP TUBE AREA. MICROSCOPIC EXAMINATION REVEALS A CUT, WHICH MAY HAVE CONTRIBUTED FOR THIS LEAK. POSSIBLY, THE CATHETER WAS MECHANICALLY DAMAGED BY A SHARP INSTRUMENT (E.G. SCALPEL) DURING DRESSING CHANGE.. WE WERE INFORMED THAT THE CUSTOMER USED ALCOHOL-BASED DISINFECTANT. THERE IS A STATEMENT IN THE PRODUCT'S IFU: "BE AWARE THAT ORGANIC SOLVENTS SUCH AS ALCOHOL OR ACETONE MAY INTERACT WITH CATHETER MATERIAL AND WEAKEN IT." AND "AVOID ANY CONTACT OF THE CATHETER TUBING TO ALCOHOL CONTAINING DISINFECTANTS." FURTHERMORE, WE HAVE A WARNING LEAFLET IN EACH BLISTER WHICH DECLARES: "NEVER USE ORGANIC SOLVENTS SUCH AS ALCOHOL DIRECTLY ON THE CATHETER, IT MAY WEAKEN THE MATERIAL. A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED, AND NO DEVIATIONS WERE FOUND EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT. THERE IS ONE ADDITIONAL COMPLAINT FOR BATCH 8113387, AND NO OTHER COMPLAINT FOR BATCH 8113386. NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT AT THIS TIME AS THERE ARE NO INDICATIONS OF A MANUFACTURING FAULT. CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT AT THIS TIME AS A MANUFACTURING FAULT COULD NOT BE DETERMINED. HOWEVER, BOTH VYGON USA AND GERMANY WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    UPON DRESSING CHANGE WITH (B)(6) , RN AND MYSELF NOTICED WET AREAS UNDER DRESSING ONCE IT WAS REMOVED. AREA WAS CLEANED PER POLICY. ONCE HOLDING PICC INSERTION SITE WE NOTICED TPN/ INTRALIPIDS LEAKING OUTSIDE OF CATHETER AND NOTICED A LEAK TOWARDS THE HUB OF THE PICC LINE. NOTIFIED (B)(6) , NNP; ORDERS TO STOP FLUIDS AND D/C PICC WERE PLACED; DEVICE REMOVED, NO BLEEDING/LEAKING AT SITE; DEVICE SEQUESTERED AND MEASURED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE FAILED SAMPLE WILL BE RETURNED TO VYGON AND WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF COMPLETION.

    Description of Event or Problem · 1

    UPON DRESSING CHANGE WITH (B)(6), RN AND MYSELF NOTICED WET AREAS UNDER DRESSING ONCE IT WAS REMOVED. AREA WAS CLEANED PER POLICY. ONCE HOLDING PICC INSERTION SITE WE NOTICED TPN/ INTRALIPIDS LEAKING OUTSIDE OF CATHETER AND NOTICED A LEAK TOWARDS THE HUB OF THE PICC LINE. NOTIFIED (B)(6), NNP; ORDERS TO STOP FLUIDS AND D/C PICC WERE PLACED; DEVICE REMOVED, NO BLEEDING/LEAKING AT SITE; DEVICE SEQUESTERED AND MEASURED ACCORDINGLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575798 NUTRILINE LONG-TERM INRAVASCULAR CATHETER LJS VYGON USA 1252.230G 20G003D

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Male Required Intervention