BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIRCLE C SILICONE CATHETER KIT

    MDR report key: 271869 · Received March 31, 2000

    Report

    Report Number
    1056436-2000-00055
    Event Type
    Other
    Date Received
    March 31, 2000
    Date of Event
    March 2, 2000
    Report Date
    March 2, 2000
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    FJS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 03/02/2000, THE DISTRIBUTOR'S SALES REP INFORMED THE MANUFACTURER'S (MFR.) REP OF THE FOLLOWING: REP REQUESTED A TUNNELING STYLET FROM THE MFR., BUT WAS TOLD THERE WAS NONE AVAILABLE. THE DISTRIBUTOR'S SALES REP MADE A PRESENTATION TO A PHYSICIAN CONCERNING THE PRODUCT IN QUESTION. WHEN THE KIT WAS OPENED TO SHOW THE PHYSICIAN HOW THE TUNNELER WORKS, THE TUNNELING STYLET WAS MISSING. ANOTHER KIT (CATALOG# AC-230KC) WAS OPENED AND THIS KIT HAD THE TUNNELER. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCLE C SILICONE CATHETER KIT CHRONIC SILICONE CATHETER FJS NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. NA SE99257

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other