BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE PICC

    MDR report key: 7685449 · Received July 13, 2018

    Report

    Report Number
    2245270-2018-00043
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    May 29, 2018
    Report Date
    September 14, 2018
    Manufacturer
    VYGON MFG
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: THIS COMPLAINT IS NOT CONFIRMED (CLASSIFICATION ACCORDING TO SOP 002). THE CUSTOMERS' FINDINGS ARE CONFIRMED. INITIALLY, THE RETURNED CATHETER COULD NOT BE FLUSHED. AFTER TREATMENT FLUSHING WAS POSSIBLE, AND A LEAKAGE COULD BE DETECTED AT THE WING. MICROSCOPIC EXAMINATION SHOWED THAT THE CATHETER WAS PARTLY TORN OUT OF THE FIXATION WING (SEE PHOTO). THIS DAMAGE WITH A ROUGH SURFACE IS TYPICAL FOR A TENSILE FRACTURE IN COMBINATION WITH THE USE OF ALCOHOL-BASED DISINFECTANTS. WE NEITHER KNOW WHICH KIND OF DISINFECTANTS HAD BEEN USED BUT IT IS ESSENTIAL TO LET DISINFECTANTS DRY COMPLETELY BEFORE THE CATHETER IS PLACED, AS ALCOHOL OR ORGANIC SOLVENTS CAN DAMAGE THE CATHETER MATERIAL. WE DO NOT KNOW WHICH KIND OF DISINFECTANTS HAD BEEN USED. AS THE CATHETER WORKED WELL FOR THREE DAYS A MANUFACTURING FAULT COULD BE EXCLUDED. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE E.G. OF CATHETER/WING IS TESTED RANDOMLY DURING MANUFACTURING. FOR THE INVOLVED BATCH THE TENSILE FORCE WAS 4,62 N UP TO 6,42 N AND THEREFORE WITHIN OUR SPECIFICATION. NO DEVIATIONS WERE FOUND WHEN LOOKING TO THE BATCH HISTORY RECORDS. THIS IS THE SECOND COMPLAINT FOR BATCH 8023295 AND THE SECOND ON CODE 4G07125203 REGARDING CATHETER LEAKAGE WITHIN THE LAST THREE YEARS. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE (E.G., OF CATHETER/WING) IS TESTED RANDOMLY DURING MANUFACTURING. FOR THE INVOLVED BATCH THE TENSILE FORCE WAS 4,62 N UP TO 6,42 N AND THEREFORE WITHIN OUR SPECIFICATION. CORRECTIVE ACTION: NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. HOWEVER, BOTH VYGON GERMANY AND VYGON USA WILL ENTER THIS INCIDENT INTO OUR COMPLAINT LOG AND CONTINUE MONITORING FOR THIS PROBLEM.

    Description of Event or Problem · 0

    NNP NOTICED THAT PICC LINE DRESSING WAS SATURATED WITH FLUID WHEN WITHDRAWING PICC CATHETER FOR PROPER PLACEMENT. NPP NOTICED THAT FLUID DROPS WERE EXITING FROM WHERE THE PLASTIC HUB MET THE CATHETER.NPP REMOVED THE PICC LINE AND PLACED A PIV FOR IVF.

    Additional Manufacturer Narrative · 1

    THE MALFUNCTIONING DEVICE HAS BEEN RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE PENDING AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION VIA FOLLOW UP MDR.

    Description of Event or Problem · 1

    NNP NOTICED THAT PICC LINE DRESSING WAS SATURATED WITH FLUID WHEN WITHDRAWING PICC CATHETER FOR PROPER PLACEMENT. NPP NOTICED THAT FLUID DROPS WERE EXITING FROM WHERE THE PLASTIC HUB MET THE CATHETER. NPP REMOVED THE PICC LINE AND PLACED A PIV FOR IVF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530220 NUTRILINE PICC LONG TERM INTRAVASCULAR CATHETER LJS VYGON MFG 1252.030G 18C010D

    Patients

    Seq Age Sex Outcome Treatment
    1