BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI-LUMEN/PSI KIT

    MDR report key: 17470625 · Received August 7, 2023

    Report

    Report Number
    9680794-2023-00580
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    April 28, 2023
    Report Date
    July 20, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    20801902121916
    PMA / PMN Number
    K002507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE 9FR SHEATH FOR ANALYSIS. DEFINITE SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED. VISUAL INSPECTION OF THE SHEATH REVEALED NO OBVIOUS DEFECTS OR ANOMALIES. THE HEMOSTASIS VALVE AND PSI DEVICE WAS LEAK TESTED ACCORDING TO THREE DIFFERENT PARAMETERS PER AMRQ-000038 REV.12: 1) LOW PRESSURE LEAK RESISTANCE TEST (AMRQ-000038 SECTION 6.1.2): THIS STATES , "USING A TEST PRESSURE OF 38-42 KPA (5.51-6.09 PSI), THERE SHALL BE NO LEAKAGE PAST THE HEMOSTASIS VALVE". THE MAC CATHETER WAS ATTACHED TO THE LAB LEAK TESTER. WITH THE DISTAL END OF THE SHEATH OCCLUDED, THE SHEATH WAS PRESSURIZED TO 42 KPA FOR 30 SECONDS. NO LEAKING WAS OBSERVED. 2) LIQUID LEAKAGE - HEMOSTASIS VALVE WITH DILATOR ADVANCED: THE PARAMETERS FROM THE LOW-PRESSURE LEAK RESISTANCE TEST WERE REPEATED WITH A LAB INVENTORY DILATOR INSERTED INTO THE SHEATH. THE SHEATH WAS PRESSURIZED TO 42 KPA FOR 30 SECONDS AND NO LEAKS WERE OBSERVED FROM THE HEMOSTASIS VALVE. 3) HIGH PRESSURE LEAK RESISTANCE TEST (AMRQ-000038 SECTION 6.1.3): THIS STATES, "WHEN TESTED IN ACCORDANCE WITH ISO 11070:, ANNEX D, USING A TEST PRESSURE OF 300-320 KPA (43.5-46.4 PSI) THERE SHALL BE NO LEAKAGE SUFFICIENT TO FORM A FALLING DROP." WITH BOTH THE DISTAL END OF THE SHEATH AND THE HEMOSTASIS VALVE OCCLUDED WITH A LAB INVENTORY OBTURATOR, EACH EXTENSION LINE WAS SEPARATELY PRESSURIZED TO 300KPA FOR 30 SECONDS. NO LEAKS WERE DETECTED FROM ANY PORTION OF THE MAC AND NO LUMEN CROSSOVER WAS OBSERVED, WHICH INDICATES THAT THE ASSEMBLY IS INTACT. THE RETURNED DEVICE PASSED ALL THREE FUNCTIONAL LEAK TESTS PERFORMED; THEREFORE, THE CUSTOMER REPORTED ISSUE COULD NOT BE REPRODUCED AT THE TIME OF THE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT INFORMS THE USER, "USE ARROW OBTURATOR, EITHER INCLUDED WITH THIS PRODUCT OR SOLD SEPARATELY, AS DUMMY CATHETER WITH HEMOSTASIS VALVE ASSEMBLY. THIS WILL ENSURE THAT LEAKAGE DOES NOT OCCUR AND INNER SEAL IS PROTECTED FROM CONTAMINATION." THE REPORT OF A LEAKING SHEATH COULD NOT BE CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES WITH THE SHEATH NOR THE VALVES. THE RETURNED MAC WAS LEAK TESTED ACCORDING TO BS EN ISO 11070 WITH AN OBTURATOR OCCLUDING THE VALVE, WITHOUT AN OBTURATOR AND WITH A LAB INVENTORY DILATOR ADVANCED THROUGH THE SHEATH. NO LEAKING OR INTER LUMEN CROSSOVER WAS OBSERVED DURING ANY OF THE TESTING PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE CUSTOMER REPORT AND FUNCTIONAL TESTING OF THE SAMPLE RECEIVED, NO PROBLEM WAS FOUND WITH THE RETURNED SAMPLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED "IV FLUIDS NOTED TO BE LEAKING OUT OF INTRODUCER." THE INTRODUCER HAD BEEN PLACED ON (B)(6) 2023 AND WAS IN USE WITH A PULMONARY ARTERY CATHETER. THE INTRODUCER WAS REMOVED ON (B)(6) 2023. A PICC LINE WAS PLACED INSTEAD. NO PATIENT HARM REPORTED. THE PATIENT WAS REPORTED TO BE DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 0

    CUSTOMER REPORTED "IV FLUIDS NOTED TO BE LEAKING OUT OF INTRODUCER." THE INTRODUCER HAD BEEN PLACED ON (B)(6) 2023 AND WAS IN USE WITH A PULMONARY ARTERY CATHETER. THE INTRODUCER WAS REMOVED ON (B)(6) 2023. A PICC LINE WAS PLACED INSTEAD. NO PATIENT HARM REPORTED. THE PATIENT WAS REPORTED TO BE DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662385 ARROW MULTI-LUMEN/PSI KIT INTRODUCER CATHETER FOZ ARROW INTERNATIONAL LLC 33F23B0611 20801902121916

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EPINEPHRINE.| EPINEPHRINE.