BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 20 CM

    MDR report key: 14794127 · Received June 23, 2022

    Report

    Report Number
    3006425876-2022-00569
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    June 3, 2022
    Report Date
    June 6, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE ARS, AN INTRODUCER NEEDLE, AND A CATHETER OVER NEEDLE SUBASSEMBLY. NO DEFINITE SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS DID NOT REVEAL ANY OBVIOUS DEFECTS OR ANOMALIES OF ANY KIND. NO CRACKS WERE OBSERVED IN THE NEEDLE HUB. THE INTRODUCER NEEDLE WAS FUNCTIONALLY TESTED WITH THE RETURNED ARS PER THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WHICH STATES, "INSERT INTRODUCER NEEDLE OR CATHETER/NEEDLE WITH ATTACHED SYRINGE OR ARROW RAULERSON SYRINGE (WHERE PROVIDED) INTO VEIN AND ASPIRATE." THE INTRODUCER NEEDLE WAS ATTACHED TO THE ARS. THE HUB OF THE INTRODUCER NEEDLE FIT SNUGLY ON THE NOSE OF THE ARS SYRINGE. IT WAS ALSO NOTED THAT THE ASSEMBLY WAS ABLE TO DRAW AND ASPIRATE WATER WITH LITTLE TO NO ISSUE. THE CONNECTION BETWEEN THE SYRINGE AND THE NEEDLE WAS COMPARED WITH ANOTHER ARS SYRINGE AND INTRODUCER NEEDLE FROM LAB INVENTORY. THE RETURNED ARS SYRINGE WAS TESTED WITH A LAB INVENTORY NEEDLE, AND THE RETURNED NEEDLE WAS TESTED WITH A LAB INVENTORY ARS SYRINGE. NO DIFFERENCES WERE DETECTED. THE HUB OF THE 18 GA INTRODUCER NEEDLE WAS TESTED WITH THE MALE LUER GAUGE AND WAS WITHIN THE SPECIFIED RANGE. THIS INDICATES THAT THE LUER CONFORMS TO ISO 594-1:1986. A DEVICE HISTORY RECORD WAS PERFORMED, AND A POTENTIALLY RELEVANT FINDING WAS IDENTIFIED. FOR MATERIAL#/LOT# K-04300-019A/71P21G0463, A NON-CONFORMANCE WAS INITIATED TO ADDRESS THE ISSUE OF A SYRINGE/NEEDLE CONNECTION DIFFICULTY; HOWEVER, AFTER FURTHER ANALYZING THIS NON-CONFORMANCE, IT WAS DETERMINED THAT THE NEEDLE HUB INVOLVED WITH THIS PAST COMPLAINT DID NOT CONFORM TO ISO 594-1:1986. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "INSERT INTRODUCER NEEDLE OR CATHETER/NEEDLE WITH ATTACHED SYRINGE OR ARROW RAULERSON SYRINGE (WHERE PROVIDED) INTO VEIN AND ASPIRATE". THE COMPLAINT OF SYRINGE/NEEDLE CONNECTION NOT SECURE WAS NOT ABLE TO BE CONFIRMED BY A COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE 18 GA INTRODUCER NEEDLE AND ARS MET ALL RELEVANT FUNCTIONAL TESTING. THE NEEDLE HUB MET ISO 594-1 REQUIREMENTS WHEN MEASURED USING A LUER GAUGE. BASED ON THE PRODUCT RETURNED, NO PROBLEM WAS FOUND ON THE SAMPLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PHYSICIAN COULD NOT CONNECT THE NEEDLE WITH THE SYRINGE (IT WOULD NOT FIT). A NEW KIT WAS OPENED TO FINISH THE P ROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PHYSICIAN COULD NOT CONNECT THE NEEDLE WITH THE SYRINGE (IT WOULD NOT FIT). A NEW KIT WAS OPENED TO FINISH THE P ROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796332 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F21H0607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown