BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

    MDR report key: 8078866 · Received November 16, 2018

    Report

    Report Number
    1820334-2018-03262
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 21, 2018
    Report Date
    November 16, 2018
    Manufacturer
    COOK INC
    Product Code
    FOZ
    PMA / PMN Number
    K033843
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INFORMATION: BRAND NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY. LOT: THE CUSTOMER REPORTED THREE POTENTIAL LOTS. 9112771, 8456074, 8377130 CONCOMITANT PRODUCTS: MEDICAL MICROCLAVE CAP MC100 AND CAREFUSION MAXZERO MZ1000-7. (B)(4). DEVICE EVALUATION THE REPORTED USED DEVICE WAS RETURNED FOR EVALUATION. BIOMATTER WAS FOUND ON THE DEVICE AND THE EXTENSION TUBES APPEARED TO HAVE BEEN CUT ABOVE THE MANIFOLD. UNKNOWN CAPS WERE RETURNED SECURED ON BLUE AD RED HUBS. A VERTICAL CRACK ALONG THE HUB WING WAS VERIFIED. LEAK TESTING CONFIRMED THE WHITE HUB TO LEAK VIA THIS CRACK. INVESTIGATION A REVIEW OF DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. A COMPLAINT HISTORY SEARCH WAS ALSO UNABLE TO BE PERFORMED DUE TO THE LACK OF A LOT NUMBER. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME, HOWEVER APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER RISK REDUCTION ACTIVITIES ARE REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE WHITE HUB ON A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER WAS FOUND CRACKED ON (B)(6) 2018. THE DEVICE WAS INSERTED ON (B)(6) 2018 AND REMOVED ON (B)(6) 2018. A REPLACEMENT DEVICE WAS INSERTED USING THE SAME INSERTION SITE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE, HOWEVER, REQUIRED AN ADDITIONAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919550 FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention