BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 14981362 · Received July 11, 2022

    Report

    Report Number
    2245270-2022-00057
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    April 13, 2022
    Report Date
    November 2, 2022
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH (B)(4). THE FAILED DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING,AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.

    Additional Manufacturer Narrative · 0

    THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH (B)(4). DUE TO THE MISSING SAMPLE, THE ROOT CAUSE OF THIS ISSUE COULD NOT BE CONFIRMED. THIS COMPLAINT CANNOT BE CLASSIFIED AS NO FAULTY SAMPLE WAS RECEIVED FROM THE HOSPITAL. HOWEVER, WE RECEIVED A SIMILAR COMPLAINT FOR THE SAME BATCH FROM THIS HOSPITAL. THERE WAS A MICROHOLE AT THE JUNCTION OF THE CATHETER WITH THE FIXATION WING. THE CATHETER TUBE WAS PARTLY TORN OUT OF THE FIXATION WING. MICROSCOPIC EXAMINATION OF THE FRACTURE PLANE SHOWED A ROUGH AND UNEVEN SURFACE, WHICH IS A TYPICAL SIGN FOR A TENSILE FRACTURE DUE TO A HIGH TENSILE LOAD. REFERENCE (B)(4) (2888). NO INFORMATION IS PROVIDED REGARDING THE USE OF AN ALCOHOL-BASED DISINFECTANT. DOCUMENTATION FOR BATCH NO. 8138680 SHOWED THAT THE CODE 4G31252400, BATCHES 8132711 AND 8147241 WERE USED TO MANUFACTURE THIS BATCH. A REVIEW OF THE BATCH HISTORY RECORDS FOR BATCH NO. 8150602 WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. BOTH BATCHES COMPLIED TO THEIR SPECIFICATION AND WERE RELEASED. EACH CATHETER IS LEAK AND FLOW TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. THE TENSILE FORCE FOR THE JUNCTION OF CATHETER TUBE AND WING FOR CODE 4G31252400, BATCH NO. 8132711 HAS A MEAN OF 5,51 N FOR THE BATCH INVOLVED. CODE 4G31252400, BATCH NO. 8147241 HAS A MEAN OF 5,20 N. THE MEAN FOR BATCH NO. 8150917 WAS 5,13 N. AT ITS MINIMUM AT 3 N, THIS IS WITHIN THE SPECIFICATION. VISUAL TESTS AND INCOMING GOODS ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. AS EACH CATHETER IS LEAK AND FLOW TESTED BEFORE PACKAGING AND THE CATHETER WAS USED UNEVENTFULLY FOR 5 DAYS BEFORE LEAKAGE OCCURRED, A MANUFACTURING DEFECT WOULD BE RATHER UNLIKELY. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT. CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AS DUE TO THE MISSING SAMPLE AND THE CATHETER WAS USED UNEVENTFULLY FOR 5 DAYS BEFORE LEAKAGE OCCURRED. THEREFORE, IT IS NOT LIKELY THAT THE LEAK REPORTED WAS A RESULT OF A MANUFACTURING DEFECT.

    Description of Event or Problem · 0

    DURING ROUTINE DRESSING CHANGE, INFANT WAS NOTED TO HAVE LEAKING AT THE PATIENT SIDE OF THE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) BUTTERFLY. LINE WAS REMOVED WITH NO OTHER ISSUES.

    Description of Event or Problem · 0

    DURING ROUTINE DRESSING CHANGE, INFANT WAS NOTED TO HAVE LEAKING AT THE PATIENT SIDE OF THE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) BUTTERFLY. LINE WAS REMOVED WITH NO OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2397240 NUTRILINE LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1252.35G 21I004D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other