BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW PI CVC KIT: 3L 7 FR X 20 CM AGB

    MDR report key: 25179106 · Received May 14, 2026

    Report

    Report Number
    9680794-2026-00398
    Event Type
    Death
    Date Received
    May 14, 2026
    Date of Event
    June 18, 2025
    Report Date
    April 22, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN #: (B)(4). SECTION B5: THE EVENT DESCRIPTION HAS BEEN SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION ABOUT THE SOURCE OF THE INFORMATION TELEFLEX RECEIVED ABOUT THE EVENT. ADDITIONAL MANUFACTURER NARRATIVE: THE REPORT TO TELEFLEX BY AN INDIVIDUAL AT THE HEALTH CARE FACILITY, WHO TELEFLEX UNDERSTANDS WAS NOT DIRECTLY INVOLVED IN THE EVENT, OF A CATHETER ALLERGIC REACTION WAS THAT A "PATIENT WITH A KNOWN CHLORHEXIDINE ALLERGY RECEIVED AN AGB CATHETER AND WENT INTO ANAPHYLAXIS AND DIED." THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "CONTRAINDICATIONS: THE ARROWG+ARD BLUE PLUS ANTIMICROBIAL CATHETER IS CONTRAINDICATED FOR PATIENTS WITH KNOWN HYPERSENSITIVITY TO CHLORHEXIDINE, SILVER SULFADIAZINE AND/OR SULFA DRUGS." BASED ON THE INFORMATION REPORTED TO TELEFLEX, USE ERROR LIKELY CAUSED THE REPORTED EVENT. A CUSTOMER IN-SERVICE WAS INITIATED TO REMIND THE USER OF THE CONTRAINDICATIONS IN THE IFUS FOR THE DEVICE. 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 TO TELEFLEX BY AN INDIVIDUAL AT THE HEALTH CARE FACILITY, WHO TELEFLEX UNDERSTANDS WAS NOT DIRECTLY INVOLVED IN THE EVENT, THAT A PATIENT WITH A KNOWN CHLORHEXIDINE ALLERGY RECEIVED AN ARROWG+ARD BLUE (AGB) CATHETER (NO ADDITIONAL DETAILS REGARDING MATERIAL OR LOT NUMBER WERE PROVIDED) AND THE PATIENT SUBSEQUENTLY WENT INTO ANAPHYLACTIC SHOCK AND DIED. EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE FURTHER DETAILS OF THE EVENT; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A KNOWN CHLORHEXIDINE ALLERGY RECEIVED AN ARROWG+ARD BLUE (AGB) CATHETER (NO ADDITIONAL DETAILS REGARDING MATERIAL OR LOT NUMBER WERE PROVIDED). THE PATIENT SUBSEQUENTLY WENT INTO ANAPHYLACTIC SHOCK AND DIED. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE FURTHER DETAILS OF THE EVENT; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284097 ARROW PI CVC KIT: 3L 7 FR X 20 CM AGB CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1