BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI CVC KIT: 2-L 8 FR X 16 CM AGB

    MDR report key: 17728582 · Received September 12, 2023

    Report

    Report Number
    9680794-2023-00666
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 18, 2023
    Report Date
    August 18, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902117110
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). A QUANTITY OF (B)(4) DEVICES WAS REPORTED. ASSOCIATED MDRS: 9680794-2023-00672, 9680794-2023-00656, 9680794-2023-00664, 9680794-2023-00665, 9680794-2023-00666, 9680794-2023-00667, 9680794-2023-00668, 9680794-2023-00669, 9680794-2023-00670, 9680794-2023-00671 THE CUSTOMER PROVIDED THREE IMAGES SHOWING THE POUCH LABEL AND LIDSTOCK OF A CVC KIT. IT WAS NOTED THAT THE POUCH LABEL IS FOR A CDC-45703-XP1A KIT; HOWEVER, THE LIDSTOCK/STICKER LABEL IS FOR A CDC-42802-XP1A KIT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORT OF AN INCORRECT POUCH LABEL WAS CONFIRMED BY COMPLAINT ANALYSIS OF THE CUSTOMER SUPPLIED PHOTOS. VISUAL ANALYSIS REVEALED THAT THE POUCH LABEL IS FOR A CDC-45703-XP1A KIT; HOWEVER, THE LIDSTOCK/STICKER LABEL IS FOR A CDC-42802-XP1A KIT. BASED ON THE CU STOMER REPORT AND THE SUPPLIED PHOTOS, PACKAGING CAUSED OR CONTRIBUTED TO THIS EVENT. A NON-CONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). A QUANTITY OF 10 DEVICES WAS REPORTED. ASSOCIATED MDRS: 9680794-2023-00672, 9680794-2023-00656, 9680794-2023-00664, 9680794-2023-00665, 9680794-2023-00667, 9680794-2023-00668, 9680794-2023-00669, 9680794-2023-00670, 9680794-2023-00671.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105026 ARROW PI CVC KIT: 2-L 8 FR X 16 CM AGB CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL LLC 36F22K0020 10801902117110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown