BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FGE CATHETER, BILIARY, DIAGNOSTIC

    MDR report key: 6327257 · Received February 13, 2017

    Report

    Report Number
    1820334-2017-00169
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Report Date
    January 16, 2017
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002110205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, TRENDS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE APPROPRIATE WARNINGS, PRECAUTIONS AND INSTRUCTIONS FOR USE. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN, ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. MEASURES HAVE BEEN PREVIOUSLY INITIATED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A LEAK DEVELOPED ON AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER AT THE JUNCTION OF THE CATHETER AND MAC-LOCK HUB. NO INFORMATION WAS PROVIDED RELATING TO THE USE OF THE DEVICE AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT INDICATE IF THIS EVENT WAS NOTED DURING TESTING PRIOR TO IMPLANT OR AFTER PATIENT CONTACT AND IMPLANTATION. IT IS NOT KNOWN IF ANY MEDICAL / SURGICAL INTERVENTION WAS NECESSITATED TO ADDRESS THIS ISSUE. SPECIFIC PATIENT DETAILS, CONDITIONS AND INDICATIONS FOR USE WERE NOT MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108182 FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A 00827002110205

    Patients

    Seq Age Sex Outcome Treatment
    1