BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE BILIARY DRAINAGE CATHETER

    MDR report key: 6463457 · Received April 6, 2017

    Report

    Report Number
    1820334-2017-00550
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    March 4, 2017
    Report Date
    June 15, 2017
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002289499
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL: ULT8.5-38-40-P-6S-HIRATA-110184. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE HUB HAD SEPARATED FROM THE CATHETER. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. THE CATHETER WAS PLACED IN THE PATIENT FOR HIP JOINT ABSCESS DRAINAGE. THE PATIENT STOOD UP WITH HER/HIS HAND PUT ON THE CATHETER WHEN CHANGING A BODY POSITION RESULTING IN SEPARATION OF THE CATHETER FROM THE HUB. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT ULTRATHANE BILIARY DRAINAGE CATHETER PLACEMENT ON (B)(6) 2017 FOR DRAINAGE OF A HIP ABSCESS. THE PATIENT ATTEMPTED TO CHANGE POSITION ON (B)(6) 2017 AND PLACED THEIR HANDS ON THE CATHETER RESULTING IN THE HUB SEPARATING FROM THE CATHETER. GAUZE WAS PLACED ON THE DEVICE UPON SEPARATION. DECREASED DRAINAGE VOLUME WAS NOTED ON (B)(6) 2017. THE CATHETER WAS SUBSEQUENTLY REMOVED AND A NEW CATHETER PLACED. NO UNINTENDED DEVICE SECTIONS REMAINED WITHIN THE PATIENT. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246630 ULTRATHANE BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A 00827002289499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention