BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW ARTERIAL LINE KIT: 20 GA. X 5"

    MDR report key: 14569499 · Received June 1, 2022

    Report

    Report Number
    9680794-2022-00348
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    May 10, 2022
    Report Date
    May 11, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    10801902193916
    PMA / PMN Number
    K171146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE ARTERIAL CATHETER FOR ANALYSIS. SIGNS OF USE IN THE FORM OF ADHESIVE RESIDUE WERE OBSERVED ON THE EXTENSION LINE. THE SEPARATED PORTION OF THE CATHETER BODY WAS NOT RETURNED FOR ANALYSIS. VISUAL ANALYSIS REVEALED THAT THE CATHETER BODY WAS SEPARATED FROM THE JUNCTURE HUB. AFTER PERFORMING DIMENSIONAL AND FUNCTIONAL TESTING, THE HUB WAS CROSS SECTIONED TO ANALYZE THE INNER CANAL OF THE JUNCTURE HUB. NO PORTION OF THE CATHETER BODY WAS OBSERVED INSIDE THE JUNCTURE HUB. THE INNER DIAMETER OF THE JUNCTURE HUB MEASURED 1.0414MM, WHICH IS CONSISTENT WITH THE CATHETER BODY OUTER DIAMETER SPECIFICATIONS OF 1.040MM-1.090MM PER THE CATHETER PRODUCT DRAWING. DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED ON THE SEPARATED CATHETER COMPONENT AS IT WAS NOT RETURNED FOR ANALYSIS. A LAB INVENTORY SYRINGE FILLED WITH WATER WAS ATTACHED TO THE CATHETER LUER HUB. WATER WAS OBSERVED EXITING OUT OF THE DISTAL HOLE IN THE JUNCTURE HUB. PERFORMED PER IFU STATEMENT "MAINTAIN CATHETER PATENCY ACCORDING TO INSTITUTIONAL POLICIES, PROCEDURES AND PRACTICE GUIDELINES. ALL PERSONNEL WHO CARE FOR PATIENTS WITH PERIPHERAL INTRAVASCULAR DEVICES MUST BE KNOWLEDGEABLE ABOUT EFFECTIVE MANAGEMENT TO PROLONG CATHETER'S DWELL TIME AND PREVENT INJURY". THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT USE SCISSORS TO REMOVE DRESSING TO REDUCE THE RISK OF CUTTING THE CATHETER". THE IFU ALSO STATES, "DO NOT USE EXCESSIVE FORCE IN REMOVING CATHETER. IF RESISTANCE IS MET ON REMOVAL, STOP AND FOLLOW INSTITUTIONAL POLICIES AND PROCEDURES FOR DIFFICULT TO REMOVE CATHETERS". THE REPORT OF A SEPARATED ARTERIAL CATHETER WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE CATHETER BODY BECAME COMPLETELY SEPARATED FROM THE JUNCTURE HUB. ADDITIONAL ANALYSIS REVEALED THAT NO PORTION OF THE CATHETER BODY WAS STILL MOLDED WITHIN THE JUNCTURE HUB. ASIDE FROM THIS, THE CATHETER MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, MANUFACTURING CAUSED OR CONTRIBUTED TO THIS EVENT. A NON-CONFORMANCE WAS INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    PATIENT WAS BROUGHT TO INTERVENTIONAL RADIOLOGY (IR) FOR FISTULOGRAM WITH POSSIBLE INTERVENTION. HOWEVER, THERE WAS AN ISSUE WITH THE ARTERIAL LINE BEFORE THE PATIENT WENT DOWN AND THE RADIAL ARTERIAL LINE WAS RETAINED IN THE PATIENT AFTER REMOVAL. THE FISTULOGRAM WAS PUT ON HOLD UNTIL THE ARTERIAL LINE ISSUE WAS RESOLVED. A RADIAL ARTERY THROMBECTOMY WAS PERFORMED AND THE CATHETER WAS REMOVED FULLY INTACT WITH BRISK BLEEDING POST THROMBECTOMY. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 0

    PATIENT WAS BROUGHT TO INTERVENTIONAL RADIOLOGY (IR) FOR FISTULOGRAM WITH POSSIBLE INTERVENTION. HOWEVER, THERE WAS AN ISSUE WITH THE ARTERIAL LINE BEFORE THE PATIENT WENT DOWN AND THE RADIAL ARTERIAL LINE WAS RETAINED IN THE PATIENT AFTER REMOVAL. THE FISTULOGRAM WAS PUT ON HOLD UNTIL THE ARTERIAL LINE ISSUE WAS RESOLVED. A RADIAL ARTERY THROMBECTOMY WAS PERFORMED AND THE CATHETER WAS REMOVED FULLY INTACT WITH BRISK BLEEDING POST THROMBECTOMY. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317379 ARROW ARTERIAL LINE KIT: 20 GA. X 5" CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN920537 UNKNOWN 10801902193916

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention NOT REPORTED| NOT REPORTED