BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPTRACK

    MDR report key: 10162727 · Received June 17, 2020

    Report

    Report Number
    1036844-2020-00189
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    April 21, 2020
    Report Date
    June 10, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K160925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 2-LUMEN PICC FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED. THE CATHETER BODY WAS ALSO INTENTIONALLY SEVERED DIRECTLY BELOW THE 35CM MARK. VISUAL ANALYSIS REVEALED THAT THE PROXIMAL EXTENSION LINE WAS SEPARATED DIRECTLY ADJACENT TO THE LUER HUB AND THE SEPARATED HUB WAS NOT RETURNED BY THE CUSTOMER. THE EDGES OF THE SEPARATION ON THE EXTENSION LINE APPEARED ROUGH AND JAGGED. IN ADDITION TO THE HUB SEPARATION, THE PROXIMAL EXTENSION LINE ALSO APPEARED TO BE PERMANENTLY STRETCHED IN PLACES. NO DEFECTS OR ANOMALIES WERE OBSERVED IN THE DISTAL EXTENSION LINE. THE PROXIMAL EXTENSION LINE LENGTH MEASURED 2.344", WHICH IS LONGER THAN THE NOMINAL VALUE OF 2.10" PER THE CATHETER GRAPHIC. THE PROXIMAL EXTENSION LINE OUTER DIAMETER MEASURED .0855", WHICH NOT WITHIN THE SPECIFICATION LIMITS OF .093"-.097" PER THE PROXIMAL EXTENSION LINE EXTRUSION GRAPHIC. THE PROXIMAL EXTENSION LINE INNER DIAMETER MEASURED .056", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .033"-.059" PER THE PROXIMAL EXTENSION LINE EXTRUSION GRAPHIC. BASED ON THE LENGTH AND OUTER DIAMETER DIMENSIONS AND THE STRETCHING OBSERVED DURING VISUAL INSPECTION, IT WAS DETERMINED THE PROXIMAL OUTER DIAMETER MEASURED OUT OF THE SPECIFICATION LIMITS DUE TO THE STRETCHING ON THE EXTRUSION DURING USE. THE DISTAL LUMEN WAS FLUSHED USING A LAB INVENTORY SYRINGE. NO LEAKS OR BLOCKAGES WERE DETECTED. A MANUAL TUG TEST CONFIRMED THE DISTAL LUMEN WAS FULLY SECURED TO THE LUER HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED". THE CUSTOMER REPORT OF SEPARATED LUER HUBS WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE PROXIMAL LUER HUB WAS SEPARATED FROM THE EXTENSION LINE; HOWEVER, THE SEPARATED HUB WAS NOT RETURNED FOR ANALYSIS. SLIGHT AREAS OF STRETCHING WERE OBSERVED IN THE PROXIMAL EXTENSION LINE WHICH LIKELY CAUSED THE EXTRUSION OUTER DIAMETER TO MEASURE OUT OF THE SPECIFICATION LIMITS. ALL OTHER DIMENSIONAL AND FUNCTIONAL REQUIREMENTS WERE MET, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. WITHOUT THE SEPARATED LUER HUB RETURNED FOR EVALUATION, THE PROBABLE CAUSE COULD NOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS: THE HUB WAS TORN OFF SOMEHOW.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: THE HUB WAS TORN OFF SOMEHOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627212 ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPTRACK CATHETER INTRAVASCULAR THERAPE LJS ARROW INTERNATIONAL INC. 23F19K0378

    Patients

    Seq Age Sex Outcome Treatment
    1