BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI CVC KIT: 4L 8.5 FR X 20 CM

    MDR report key: 17122516 · Received June 13, 2023

    Report

    Report Number
    9680794-2023-00453
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    April 18, 2023
    Report Date
    June 9, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    30801902117275
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). A TOTAL OF 5 DEVICES WERE REPORTED. ASSOCIATED MDR#S 9680794-2023-00460, 9680794-2023-00459, 9680794-2023-00458, 9680794-2023-00461. THE CUSTOMER PROVIDED THREE IMAGES FOR ANALYSIS. THE IMAGES SHOW AN ASK KIT WITHIN A BOX THAT CONTAINS A LABEL OF A DIFFERENT MATERIAL. THE CUSTOMER RETURNED ONE UNOPENED MAC KIT WITH FINISHED GOOD MATERIAL ASK-11142-NSU AND LOT 13F22L0806. VISUAL ANALYSIS REVEALED THAT THE KIT WAS RETURNED WITHIN A BOX CONTAINING A LABEL WITH MATERIAL CDC-45854-P1A AND LOT 13F22L0806. THE KIT WAS OPENED TO FURTHER ANALYZE THE COMPONENTS. AN ADDITIONAL LABEL WITHIN THE KIT STATED THAT THE COMPONENTS BELONGED TO MATERIAL CDC-45854-P1A. ADDITIONALLY, THE COMPONENTS WITHIN THE KIT WERE IDENTIFIED TO BELONG TO MATERIAL CDC-45854-P1A. THEREFORE, IT IS DETERMINED THAT THE PRODUCT LIDSTOCK PROVIDED WITH THE KIT IS INCORRECT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE CUSTOMER REPORT OF AN INCORRECT LABEL WAS CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. A DISCREPANCY WAS NOTED BETWEEN THE BOX LABEL AND PRODUCT LIDSTOCK LABEL. THE COMPONENTS WITHIN THE KIT WERE OBSERVED TO BELONG TO KIT WITH FINISHED GOOD CDC-45854-P1A AND LOT 13F22L0806, WHICH IS CONSISTENT WITH THE BOX LABEL. THEREFORE, BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, PRODUCT LIDSTOCK PACKAGING LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. A NON CONFORMANCE WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CUSTOMER RECEIVED SHIPMENT OF 1 CASE THAT WAS LABELED CDC-45854-P1A ON THE CORRAGATE BOX, HOWEVER INSIDE THE CASE WAS PRODUCT FOR ASK-11142-NSU. THE LIDSTOCK ON THE PRODUCT WAS NOTED TO BE INCORRECT. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874760 ARROW PI CVC KIT: 4L 8.5 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC IPN036455 13F22L0806 30801902117275

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown