BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS CATHETER

    MDR report key: 16723596 · Received April 12, 2023

    Report

    Report Number
    16723596
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    February 13, 2023
    Report Date
    April 5, 2023
    Manufacturer
    TELEFLEX INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT (PT) HAD MULTIPLE KNOWN ALLERGIES AND UNDERWENT ALLERGY TEST FOLLOWING RECENT ANAPHYLACTIC REACTION AFTER INTUBATION. SURGERY CANCELLED AND ALLERGY TESTING DONE REVEALED CHG (CHLORHEXIDINE GLUCONATE) ALLERGY. TWO MONTHS LATER, RETURNED TO OR. AFTER CENTRAL LINE PLACED - DEVELOPED HYPOTENSION, TREATED FOR ANAPHYLAXIS. SUSPECTED SOURCE CENTRAL LINE - CHLORHEXIDINE COATING. PATIENT PREPPED WITH BETADINE FOR BOTH LINE INSERTIONS. LINE REMOVED. NEW NON-COATED CHG INSERTED. DECISION TO PROCEED WITH SURGICAL PROCEDURE. PT REQUIRED 125 MG OF SOLU-CORTEF AND HAD ALREADY REC'D DECADRON FOR PONV (POSTOPERATIVE NAUSEA AND VOMITING) PRIOR TO ANAPHYLACTIC EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108552 ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS CATHETER INTRODUCER, CATHETER DYB TELEFLEX INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Female Required Intervention| L| H