BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCU-FLO RESV 14MM

    MDR report key: 724292 · Received June 9, 2006

    Report

    Report Number
    1226348-2006-00150
    Event Type
    Other
    Date Received
    June 9, 2006
    Manufacturer
    CODMAN & SHURTLEFF, INC./ MEDOS S.A.
    Product Code
    JXG
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THIS COMPLAINT IT HAS BEEN ACKNOWLEDGED THAT THE CODMAN CATALOG MAY CAUSED SOME CONFUSION PERTAINING TO PRODUCT COMPONENTS. A CORRECTIVE ACTION HAS BEEN PUT INTO PLACE, IN WHICH MARKETING IS CREATING AN INSERT THAT CLARIFIES THAT THE PRODUCT DOES NOT CONTAIN THE VENTRICULAR CATHETER AND CONNECTOR. AT THE PRESENT TIME AND BASED ON THIS ISOLATED NATURE OF THIS COMPLAINT, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND/OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    SALES REP REPORTS THAT THE CUSTOMER PURCHASED PRODUCT CODE 82-1401 AND WAS EXPECTING THE BARIUM VENTRICULAR CATHETER AND STRAIGHT CONNECTOR TO BE PROVIDED WITH THE PRODUCT. THE VENTRICULAR CATHETER AND STRAIGHT CONNECTOR ARE NOT INTENDED TO BE PROVIDED WITH PRODUCT CODE 82-1401. PT WAS IN THE O.R. FOR APPROX FIVE HOURS WAITING FOR A VENTRICULAR CATHETER AND A STRAIGHT CONNECTOR THAT WAS OBTAINED FROM ANOTHER HOSP. PT IS DOING FINE. HOSP DID NOT RELEASE ANY PT'S INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-FLO RESV 14MM SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC./ MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other