BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW INTERNATIONAL, INC.

    MDR report key: 532216 · Received June 10, 2004

    Report

    Report Number
    MW1032339
    Event Type
    Injury
    Date Received
    June 10, 2004
    Date of Event
    June 3, 2004
    Report Date
    June 9, 2004
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ENCOUNTERS ANAPHYLAXIS DURING ELECTIVE BOWEL SURGERY. PRIOR TO THIS SURGERY, PT HAD A CENTRAL VENOUS CATHETER PLACED. THE PT HAD A DOCUMENTED ALLERGY TO SULFA. IT WAS DISCOVERED THAT THE CATHETER WAS COATED WITH SULFA. ONLY AFTER CLOSE INSPECTION OF THE PRODUCT PACKAGING WAS IT OBVIOUS THAT PLACEMENT OF THESE CATHETERS IN PTS WHO ARE KNOWN OR SUSPECTED TO BE HYPERSENSITIVE TO CHLOREHEXIDINE GLUCONATE (CHG), SILVER, AND/OR SULFA IS CONTRAINDICATED. IN ADDITION, PACKAGING DIFFERENCES BETWEEN THE COATED VS. NON-COATED CATHETERS IS MINISCULE. FACILITY BELIEVES THAT THE MANFACTURER OF THESE WIDELY - USED CATHETERS SHOULD RE-DESIGN PACKAGING TO HIGHLIGHT WARNINGS MORE CLEARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL, INC. CENTRAL VENOUS CATHETER DQO ARROW INTERNATIONAL, INC. AK-45703-ASK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R