BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHE

    MDR report key: 2150512 · Received June 23, 2011

    Report

    Report Number
    1820334-2011-00340
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 7, 2011
    Manufacturer
    COOK INC
    Product Code
    DQO
    PMA / PMN Number
    K033843
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE UNK AS LOT IS UNK. (B)(4). SEPARATES IS NOT SPECIFICALLY ADDRESSED. NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH, CORRECT OUTSIDE DIMENSION AND OTHER SURFACE IMPERFECTIONS PRIOR TO FURTHER PROCESSING AND PRIOR TO TRANSPORT. THIS DEVICE IS SUPPLIED WITH AN IFU, THAT PROVIDES INFO REGARDING INTENDED USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, SUGGESTED CATHETER MAINTENANCE, AND INSTRUCTIONS FOR USE. W/O THE COMPLAINT DEVICE, WE CANNOT MAKE A DEFINITE ROOT CAUSE ANALYSIS. WHEN WE HAVE SEEN THIS TYPE OF DEVICE FAILURE IN THE PAST, IT HAS GENERALLY BEEN ASSOCIATED WITH THE WIRE GUIDE BEING DAMAGED BY WITHDRAWAL THROUGH THE NEEDLE (SEE WARNING LABEL) OR OTHER INSTRUMENT. LESS FREQUENTLY, PT ANATOMY MAKES WITHDRAWAL OF THE WIRE GUIDE DIFFICULT RESULTING IN SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPECIFICATION. THE EVENT DESCRIPTION STATES "TRIED TO REMOVE THE WIRE GUIDE FROM THE CATHETER, THE WIRE BROKE" INDICATES THAT EITHER THE WIRE GUIDE WAS DAMAGED DURING THE PROCEDURE OR POSSIBLY HAD BECOME KINKED DUE TO TORTUOUS ANATOMY WHICH PREVENTED ITS WITHDRAWAL THROUGH THE CATHETER. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ASSESSMENT.

    Description of Event or Problem · 1

    DURING THE SUBCLAVIAN VEIN INSERTION OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY ON A MALE PT (B)(6), THE INSERTION WAS UNEVENTFUL. HOWEVER, WHEN THE PHYSICIAN TRIED TO REMOVE THE WIRE GUIDE FROM THE CATHETER, THE WIRE BROKE AND THE PT WAS SENT TO INTERVENTIONAL RADIOLOGY TO RETRIEVE IT. IT WAS RETRIEVED AND THE PT DID WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHE DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention