BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYREX PRE-FILLED CATHETER FLUSH SYRINGE

    MDR report key: 924543 · Received October 8, 2007

    Report

    Report Number
    2027791-2007-00001
    Event Type
    Injury
    Date Received
    October 8, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 8, 2007
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL CENTER HAD CONTACTED SALES REP WITH A REPORT ABOUT AN INCIDENT WITH A SALINE FLUSH ON A PT WHO EXPERIENCED CARDIOPULMONARY ARREST AFTER ADMINISTRATION. NO FURTHER INFO IS AVAILABLE REGARDING PT RECOVERY. HOSPITAL HAS BEEN CONTACTED SEVERAL TIMES, BUT HAS REFUSED TO PROVIDE FURTHER INFO TO THE MFR (EXCELSIOR MEDICAL CORP). THIS REPORT IS BEING FILLED OUT AS AN EXCESS OF CAUTION AND BASED ON AVAILABLE INFO AT THIS TIME. REPORTED: IV BAG WAS ALSO INVOLVED. MFR WILL CONTINUE TO ATTEMPT TO CONTACT HOSPITAL IN ORDER TO COLLECT ADD'L INFO. A CUSTOMER COMPLAINT WAS INITIATED TO ADDRESS THIS INCIDENT.

    Description of Event or Problem · 1

    MEDICAL CENTER HAD CONTACTED SALES REP WITH A REPORT ABOUT AN INCIDENT WITH A SALINE FLUSH ON A PT WHO EXPERIENCED CARDIOPULMONARY ARREST AFTER ADMINISTRATION. NO FURTHER INFO IS AVAILABLE REGARDING PT RECOVERY. HOSPITAL HAS BEEN CONTACTED SEVERAL TIMES, BUT HAS REFUSED TO PROVIDE FURTHER INFO TO THE MFR (EXCELSIOR MEDICAL CORP). THIS REPORT IS BEING FILLED OUT AS AN EXCESS OF CAUTION AND BASED ON AVAILABLE INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYREX PRE-FILLED CATHETER FLUSH SYRINGE SALINE FLUSH SYRINGE FPA EXCELSIOR MEDICAL CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other NOT AVAILABLE