BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW CVC SET: 4-LUMEN 8.5FR X 16CM

    MDR report key: 17321124 · Received July 13, 2023

    Report

    Report Number
    3006425876-2023-00660
    Event Type
    Death
    Date Received
    July 13, 2023
    Date of Event
    May 23, 2023
    Report Date
    June 19, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORT OF A CATHETER RELATED ALLERGIC REACTION WAS CONFIRMED BASED ON THE CUSTOMER REPORT. THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS, WHICH WAS A COPY OF THE PRODUCT LABEL INFORMATION. A COMPLETE VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE CUSTOMER RAISED CONCERNS STATING THAT THE LABEL CONTRAINDICATIONS WERE TOO SMALL. PRODUCT LIDSTOCK WAS REVIEWED, THE AGB ICON APPEARS IN TWO LOCATIONS: LOCATION 1: ADJACENT TO THE CATALOG AND ABOVE THE DEVICE DESCRIPTION. LOCATION 2: BOTTOM LEFT CORNER. ADDITIONALLY, THE CONTRAINDICATION APPEARS: "THE ARROWG+ARD BLUE ANTIMICROBIAL CATHETER IS CONTRAINDICATED FOR PATIENTS WITH KNOWN HYPERSENSITIVITY TO CHLORHEXIDINE, SILVER SULFADIAZINE AND/OR SULFA DRUGS." THE INSTRUCTIONS FOR USE (IFU), WHICH WAS INCLUDED IN THE DEVICE PACKAGING, WAS REVIEWED AND IT STATED, "CONTRAINDICATIONS: THE ARROWG+ARD BLUE ANTIMICROBIAL CATHETER IS CONTRAINDICATED FOR PATIENTS WITH KNOWN HYPERSENSITIVITY TO CHLORHEXIDINE, SILVER SULFADIAZINE AND/OR SULFA DRUGS." A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON POTENTIAL LOTS FROM SALES HISTORY, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THEREFORE, BASED ON THE REPORTED EVENT AND CONFIRMATION OF THE PATIENT HAVING A KNOWN ALLERGY, UNINTENTIONAL USE ERROR (PATIENT CONDITION) LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED AN ARROW AGB QUAD LUMEN WAS PLACED IN A PATIENT WITH A KNOWN ANAPHYLAXIS ALLERGY TO CHLORHEXIDINE. IT WAS REPORTED "THE PATIENT SUBSEQUENTLY PASSED AWAY ALTHOUGH THERE IS NO SUGGESTION THAT THE ARROW AGB CVC WAS A FACTOR IN THE DEATH." CUSTOMER REPORTED CONCERN THAT THERE IS ONLY A SMALL AGB SYMBOL ALONG WITH A CONTRAINDICATION STATEMENT ON THE LABEL. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ARROW AGB QUAD LUMEN WAS PLACED IN A PATIENT WITH A KNOWN ANAPHYLAXIS ALLERGY TO CHLORHEXIDINE. IT WAS REPORTED "THE PATIENT SUBSEQUENTLY PASSED AWAY ALTHOUGH THERE IS NO SUGGESTION THAT THE ARROW AGB CVC WAS A FACTOR IN THE DEATH." CUSTOMER REPORTED CONCERN THAT THERE IS ONLY A SMALL AGB SYMBOL ALONG WITH A CONTRAINDICATION STATEMENT ON THE LABEL. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142730 ARROW CVC SET: 4-LUMEN 8.5FR X 16CM CATHETER, INTRAVASCULAR, THERAPEUTIC FOZ ARROW INTERNATIONAL LLC IPN030923

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death NOT REPORTED| NOT REPORTED