BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW CVC KIT: 2-LUMEN 4 FR X 5 CM

    MDR report key: 14197151 · Received April 25, 2022

    Report

    Report Number
    9680794-2022-00254
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    January 26, 2022
    Report Date
    April 4, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE, 2-LUMEN CVC FOR ANALYSIS. SIGNS OF USE IN THE FORM OF A BIOLOGICAL MATERIAL WAS OBSERVED ON THE PROXIMAL LUER HUB. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES OF ANY KIND. THE CATHETER BODY LENGTH FROM THE JUNCTURE HUB TO THE DISTAL TIP MEASURED 2 1/16" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 1 29/32"- 2 5/16" PER THE CATHETER PRODUCT DRAWING. THE CATHETER BODY OUTER DIAMETER MEASURED .0555" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0540"-.0580" PER THE CATHETER EXTRUSION PRODUCT DRAWING. THE CATHETER WAS INITIALLY FLUSHED. NO BLOCKAGES WERE PRESENT. THE DISTAL END OF THE CATHETER BODY WAS THEN CLAMPED AND BOTH LUMENS WERE PRESSURIZED WITH A LAB INVENTORY SYRINGE. NO LEAKS WERE DETECTED. BOTH LUMENS WERE THEN CONNECTED TO THE LEAK TESTER AND PRESSURIZED IN ACCORDANCE WITH BS EN ISO 10555-1 ANNEX C (REFERENCED IN AMRQ-000071 REV 12), "NO CATHETER LIQUID LEAKAGE SHALL OCCUR IN THE FORM OF A FALLING DROP OF WATER IN 30 SECONDS". EACH OF THE LUMENS WERE PRESSURIZED TO 300 KPA WITH THE DISTAL END OF CATHETER OCCLUDED. THE PRESSURE WAS HELD FOR 30 SEC AND THE CATHETER BODY WAS MONITORED FOR LEAKS. NO LEAKS WERE DETECTED. THE IFU PROVIDED WITH THE REPORTED FINISHED GOOD CAUTIONS THE USER, "PREPARE THE CATHETER FOR INSERTION BY FLUSHING EACH LUMEN AND CLAMPING OR ATTACHING THE INJECTION CAPS TO THE APPROPRIATE PIGTAILS". THE REPORT OF A CATHETER BODY RUPTURE WAS NOT ABLE TO BE CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL AND FUNCTIONAL ANALYSIS DID NOT REVEAL ANY OBVIOUS DEFECTS OR ANOMALIES WITH THE RETURNED CATHETER. THE CATHETER MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS INCLUDING LEAK TESTING PERFORMED PER BS EN ISO 10555-1 ANNEX C. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, NO PROBLEM WAS FOUND WITH THE RETURNED DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. CORRECTED DATA: SECTION D.1.-BRAND NAME CORRECTED TO ARROW CVC KIT: 2-LUMEN 4 FR X 5 CM SECTION D.4.-CATALOG# CORRECTED TO AK-22402.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "CENTRAL LINE IN PLACE IN RIGHT INTERNAL JUGULAR VEIN. AT SHIFT CHANGE, SITE NOTED TO BE RED AND EDEMATOUS. IMMEDIATELY STOPPED INFUSIONS, REMOVED LINE AND ADMINISTERED HYALURONIDASE. MS'S WERE MADE AWARE. IV LINE INFILTRATED.". ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT'S OVERALL CONDITION WAS UNCHANGED AS FAR AS VITAL SIGNS. THE RIGHT NECK AND CHIN WERE EDEMATOUS AND REDDENED. DUE TO THE POTASSIUM THAT WAS RUNNING THROUGH THE LINE, THERE WAS A RISK FOR EXTRAVASATION; THEREFORE, HYALURONIDASE WAS ADMINISTERED PER HOSPITAL POLICY. NO FURTHER INJURY WAS OBSERVED IN THE DAYS FOLLOWING.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "CENTRAL LINE IN PLACE IN RIGHT INTERNAL JUGULAR VEIN. AT SHIFT CHANGE, SITE NOTED TO BE RED AND EDEMATOUS. IMMEDIATELY STOPPED INFUSIONS, REMOVED LINE AND ADMINISTERED HYALURONIDASE. MS'S WERE MADE AWARE. IV LINE INFILTRATED.". ADDITIONAL INFORMATION RECEVIED REPORTS THE PATIENT'S OVERALL CONDITION WAS UNCHANGED AS FAR AS VITAL SIGNS. THE RIGHT NECK AND CHIN WERE EDEMATOUS AND REDDENED. DUE TO THE POTASSIUM THAT WAS RUNNING THROUGH THE LINE, THERE WAS A RISK FOR EXTRAVASATION; THEREFORE, HYALURONIDASE WAS ADMINSERED PER HOSPITAL POLICY. NO FURTHER INJURY WAS OBSERVED IN THE DAYS FOLLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183386 ARROW CVC KIT: 2-LUMEN 4 FR X 5 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention N/A.| N/A.