BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW CVC SET: 4-LUMEN 8.5FR X 16CM

    MDR report key: 11109504 · Received January 4, 2021

    Report

    Report Number
    3006425876-2021-00005
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    November 24, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER RETURNED ONE 4-LUMEN CVC FOR EVALUATION. THE CATHETER CONTAINED OBVIOUS SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL. VISUAL EXAMINATION OF THE CATHETER DID NOT REVEAL ANY DEFECTS OR ANOMALIES. NO KINKS, HOLES, OR CUTS WERE OBSERVED. THE TOTAL LENGTH OF THE CATHETER MEASURED TO BE 175 MM WHICH IS WITHIN SPECIFICATIONS OF 157-177 MM PER PRODUCT DRAWING. THE INNER DIAMETER OF THE MEDIAL LUMEN MEASURED TO BE 1.45 MM WHICH IS WITHIN SPECIFICATIONS OF 1.42-1.50 MM PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE MEDIAL LUMEN MEASURED TO BE 2.18 MM WHICH IS WITHIN SPECIFICATIONS OF 2.13-2.21 MM PER PRODUCT DRAWING. THIS INDICATES THAT THE WALL THICKNESS MEASURED WITHIN SPECIFICATIONS. ALL FOUR EXTENSION LINES OF THE RETURNED CATHETER WERE TESTED FOR LIQUID LEAKAGE PER AMRQ-000071 REV. 12 (BS EN ISO 10555-1 ANNEX C) WHICH STATES THAT NO LIQUID LEAKAGE SHOULD FORM IN ONE OR MORE FALLING DROPS OF WATER WHEN TESTED AT 300KPA FOR 30 SECONDS. THE CATHETER WAS ATTACHED TO THE LEAK TESTER , THE DISTAL END WAS OCCLUDED, AND THE LEAK TESTER WAS TURNED TO 300 KPA FOR 30 SECONDS. NO LEAKS WERE DETECTED FROM ANY REGION OF THE CATHETER, INCLUDING THE EXTENSION LINES; THEREFORE, THE SAMPLE PASSED FUNCTIONAL TESTING. A MANUAL TUG TEST CONFIRMED ALL FOUR EXTENSION LINES WERE FULLY SECURED WITHIN THEIR RESPECTIVE HUBS. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE PROVIDED WITH THIS KIT CAUTIONS THE USER, "DO NOT SUTURE DIRECTLY TO OUTSIDE DIAMETER OF CATHETER TO MINIMIZE THE RISK OF CUTTING OR DAMAGING THE CATHETER OR IMPEDING CATHETER FLOW." THE CUSTOMER REPORT OF AN EXTENSION LINE LEAK COULD NOT BE CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CATHETER PASSED ALL RELEVANT VISUAL, DIMENSIONAL, AND FUNCTIONAL TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON A POTENTIAL LOT IDENTIFIED IN SALES HISTORY WITH NO RELEVANT FINDINGS. NO PROBLEM WAS FOUND WITH THE RETURNED SAMPLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "GTN INFUSION WAS BEING ADMINISTERED VIA BLUE LUMEN OF THE ARROW 16CM CENTRAL LINE AT A RATE OF 1ML/HR (MG/ML). GTN INFUSION STOPPED AND THE LINE WAS ASPIRATED 10ML AND FLUSHED 10ML NORMAL SALINE. SIGNIFICANT DROP IN PATIENT'S BLOOD PRESSURE CAUSING REQUIREMENT FOR INOTROPES. THE BLUE LUMEN WAS CAPPED AND LABELLED TO STOP FURTHER USE AS SUSPICION OF GTN ADSORBING TO LINE." IT WAS REPORTED THE PATIENT'S CONDITION WAS "UNCHANGED, THEY HAD A TRANSIENT CHANGE IN BLOOD PRESSURE WHICH RESOLVED QUICKLY".

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "GTN INFUSION WAS BEING ADMINISTERED VIA BLUE LUMEN OF THE ARROW 16CM CENTRAL LINE AT A RATE OF 1ML/HR (MG/ML). GTN INFUSION STOPPED AND THE LINE WAS ASPIRATED 10ML AND FLUSHED 10ML NORMAL SALINE. SIGNIFICANT DROP IN PATIENT'S BLOOD PRESSURE CAUSING REQUIREMENT FOR INOTROPES. THE BLUE LUMEN WAS CAPPED AND LABELLED TO STOP FURTHER USE AS SUSPICION OF GTN ADSORBING TO LINE." IT WAS REPORTED THE PATIENT'S CONDITION WAS "UNCHANGED, THEY HAD A TRANSIENT CHANGE IN BLOOD PRESSURE WHICH RESOLVED QUICKLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5239 ARROW CVC SET: 4-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GLYCERYL TRINITRATE (GTN)| GLYCERYL TRINITRATE (GTN)| GLYCERYL TRINITRATE (GTN)