BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AM/AT PI MIDLINE 2-L FG: 5.5FR X 15CM

    MDR report key: 14846333 · Received June 28, 2022

    Report

    Report Number
    9680794-2022-00405
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 14, 2022
    Report Date
    June 14, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K161313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE IMAGE SHOWING A STICKER LABEL. THE MATERIAL#/LOT# ON THE LABEL IS ASK-41552-JHVA1/13F22C0757. IT WAS DETERMINED THAT THIS MATERIAL NUMBER DOES NOT GO WITH THE LOT NUMBER. BASED ON THIS DISCREPANCY, THE ISSUE OF AN INCORRECT LIDSTOCK WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. TWO DEVICE HISTORY RECORD REVIEWS WERE PERFORMED (ONE OF THE ASK-41541-JHVA1/13F22C0757 FINISHED GOOD, AND ONE ON ASK-41552-JHVA1/23F18M0457). A RELEVANT FINDING WAS IDENTIFIED. A SHIP HOLD WAS INITIATED BY MORRISVILLE DUE TO THE MISMATCH OF PRODUCT ASK-41552-JHVA1 AND ASK-41541-JHVA1. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "READ ALL PACKAGE INSERT WARNINGS , PRECAUTIONS AND INSTRUCTIONS PRIOR TO USE. FAILURE TO DO SO MAY RESULT IN SEVERE PATIENT INJURY OR DEATH". THE REPORT OF INCORRECT LIDSTOCK WAS CONFIRMED THROUGH ANALYSIS OF THE CUSTOMER SUPPLIED PHOTO. VISUAL ANALYSIS REVEALED THAT THE LOT NUMBER LISTED DOES NOT MATCH WITH THE MATERIAL NUMBER LISTED. BASED ON THE CUSTOMER REPORT AND THE PHOTO PROVIDED, THE ROOT CAUSE FOR THIS ISSUE IS DESIGN (LABELING) RELATED. A NON-CONFORMANCE WAS INITIATED TO ADDRESS THE ISSUE OF A LABELING MISMATCH. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER OPENED KIT DURING PROCEDURE AND WHAT WAS LABELED A DOUBLE LUMEN MIDLINE WAS ACTUALLY A SINGLE LUMEN MIDLINE. THE MIDLINE WAS STILL PLACED WITHOUT INCIDENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 0

    CUSTOMER OPENED KIT DURING PROCEDURE AND WHAT WAS LABELED A DOUBLE LUMEN MIDLINE WAS ACTUALLY A SINGLE LUMEN MIDLINE. THE MIDLINE WAS STILL PLACED WITHOUT INCIDENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937627 ARROW AM/AT PI MIDLINE 2-L FG: 5.5FR X 15CM CATHETER,INTRAVASCULAR,THERAPE FOZ ARROW INTERNATIONAL LLC 13F22C0757

    Patients

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