BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI JACC KIT: 3L 6 FR X 25 CM CG+

    MDR report key: 22412390 · Received July 7, 2025

    Report

    Report Number
    9680794-2025-00539
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LJS
    PMA / PMN Number
    K153423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE COMPLAINT OF INSERTING THE 25CM CATHETER WITH ITS TRANSPARENT PROTECTIVE TUBING WAS ABLE TO BE CONFIRMED BY THE PHOTO. BASED ON THE PHOTO, THE PROTECTIVE SLEEVE APPEARS TO HAVE BEEN INSERTED ALONG WITH THE CATHETER. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "RETRACT CONTAMINATION GUARD." IT ALSO STATES, "READ ALL PACKAGE INSERT WARNINGS, PRECAUTIONS AND INSTRUCTIONS PRIOR TO USE. FAILURE TO DO SO MAY RESULT IN SEVERE PATIENT INJURY OR DEATH." VISUAL ANALYSIS OF THE CUSTOMER PHOTO AND THE CUSTOMER DESCRIPTION STATING, "DURING REMOVAL OF THE MISPLACED LIJ, FELLOW NOTICED THAT THE 25CM CATHETER WITH THE THIN TRANSPARENT SHEATH COVERING THE ENTIRE LENGTH OF THE CATHETER HAD ALSO BEEN INTRODUCED INADVERTENTLY ALONG WITH THE CATHETER INTO THE VEIN. HOWEVER, NO HARM OCCURRED; AND FELLOW DOCUMENTED THE REMOVAL OF THE ENTIRE SHEATH ALONG WITH THE CVC." THE IFU PROVIDED WITH THIS KIT WARNS THE USER, "RETRACT CONTAMINATION GUARD. READ ALL PACKAGE INSERT WARNINGS, PRECAUTIONS AND INSTRUCTIONS PRIOR TO USE. FAILURE TO DO SO MAY RESULT IN SEVERE PATIENT INJURY OR DEATH." THEREFORE, THE ROOT CAUSE FOR THIS COMPLAINT IS INTENTIONAL USE ERROR. A CUSTOMER IN-SERVICE REQUEST IS BEING INITIATED TO FURTHER EDUCATE THE CUSTOMER ON HOW TO PROPERLY USE THE DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED " DURING REMOVAL OF THE MISPLACED LIJ, FELLOW NOTICED THAT THE 25CM CATHETER WITH THE THIN TRANSPARENT SHEATH COVERING THE ENTIRE LENGTH OF THE CATHETER HAD ALSO BEEN INTRODUCED INADVERTENTLY ALONG WITH THE CATHETER INTO THE VEIN. HOWEVER, NO HARM OCCURRED; AND FELLOW DOCUMENTED THE REMOVAL OF THE ENTIRE SHEATH ALONG WITH THE CVC." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

    Description of Event or Problem · 0

    IT WAS REPORTED " DURING REMOVAL OF THE MISPLACED LIJ, FELLOW NOTICED THAT THE 25CM CATHETER WITH THE THIN TRANSPARENT SHEATH COVERING THE ENTIRE LENGTH OF THE CATHETER HAD ALSO BEEN INTRODUCED INADVERTENTLY ALONG WITH THE CATHETER INTO THE VEIN. HOWEVER, NO HARM OCCURRED; AND FELLOW DOCUMENTED THE REMOVAL OF THE ENTIRE SHEATH ALONG WITH THE CVC." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950638 ARROW PI JACC KIT: 3L 6 FR X 25 CM CG+ CATHETER INTRAVASCULAR THERAPE LJS ARROW INTERNATIONAL LLC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.| NOT REPORTED.