BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 6721079 · Received July 18, 2017

    Report

    Report Number
    1820334-2017-01659
    Event Type
    Injury
    Date Received
    July 18, 2017
    Date of Event
    June 5, 2017
    Report Date
    January 24, 2018
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002064843
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE 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. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. A REVIEW OF COMPLAINT HISTORY SEARCH REVEALED THIS TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER 7726482. ALTHOUGH IT WAS INITIALLY STATED BY THE USER FACILITY THAT THE DEVICE WOULD BE RETURNED, THE USED DEVICE WAS NOT RETURNED FOR EVALUATION. REPEATED ATTEMPTS TO OBTAIN THE USED DEVICE WERE NOT ACKNOWLEDGED. A SIMILAR COMPLAINT, (B)(4), INVOLVING AN ULTRATHANE BILIARY DRAINAGE CATHETER COMPLAINT WITH RPN ULT8.5-38-40-P-6S-HIRATA-110184 WHERE THE CATHETER SEPARATED FROM THE HUB WAS USED TO EVALUATE THIS COMPLAINT. IN THIS SIMILAR COMPLAINT, THE PATIENT STOOD UP WITH HER/HIS HAND PUT ON THE CATHETER, WHICH RESULTING IN SEPARATION OF THE CATHETER FROM THE HUB. IT WAS CONCLUDED IN THE SIMILAR COMPLAINT THAT THE PATIENT MAY HAVE INADVERTENTLY PULLED THE CATHETER FROM THE HUB WHILE TRYING TO STABILIZE HIMSELF. IN THIS COMPLAINT, ALTHOUGH THE PHYSICIAN BELIEVES THAT THE FAILURE MAY BE A MANUFACTURING ISSUE, THE REGISTERED NURSE (RN) BELIEVES THIS MAY BE RELATED TO THE PATIENT'S AGITATION AND WITHDRAWAL SYMPTOMS. THE MANUFACTURING DOCUMENTS REVIEWED SHOWED NO DISCREPANCIES. NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS HAVE BEEN NOTED AND MULTIPLE RISK CONTROLS ARE IN PLACE TO MITIGATE THE RISK OF THIS TYPE OF FAILURE. VALIDATED ACCEPTANCE CRITERION FOR TENSILE STRENGTH IS 10N, WHICH IS APPROXIMATELY 2.25 POUNDS-FORCE. IT IS FEASIBLE THAT THE AGITATED STATE OF THE PATIENT MAY HAVE CAUSED TENSILE PRESSURES PLACED ON THE PROXIMAL FITTING TO EXCEED THE 10N VALIDATED PARAMETER. HOWEVER, WITHOUT THE ACTUAL PRODUCT FOR EVALUATION, THERE IS NO WAY TO DEFINITIVELY STATE OR EVALUATE THE SOURCE OF THIS COMPLAINT FAILURE. IF THIS PRODUCT BECOMES AVAILABLE IN THE FUTURE, THE CASE WILL BE REOPENED AND REEVALUATED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE ACTUAL CAUSE OF THIS FAILURE AT THIS TIME WILL BE DOCUMENTED AS INCONCLUSIVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THIS EVENT TO FDA UNDER USER FACILITY MEDWATCH REPORT (UF REPORT# (B)(4)) ON JUN 06, 2017. COOK MEDICAL RECEIVED THIS REPORT FROM THE FDA ON JUN 22, 2017 WHICH WAS NOT INCLUDED WITH THE PREVIOUSLY SUBMITTED REPORT.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT STATUS POST THORACENTESIS RECEIVED A ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER AS A CHEST TUBE FOR DRAINAGE OF A LARGE PARA PNEUMONIC PLEURAL EFFUSION. THE IMPLANT DATE IS NOT KNOWN. THE CUSTOMER REPORTED THAT THE NURSE RETURNED TO THE PATIENTS' ROOM AND DISCOVERED THAT THE CHEST TUBE WAS DISCONNECTED. THE NURSE CLAMPED THE TUBE AND FOUND THAT THE TUBE WAS BROKEN OFF AT THE JUNCTION OF THE TUBE AND STOPCOCK. THE PHYSICIAN BELIEVES THIS EVENT MAY BE A MANUFACTURING ISSUE, HOWEVER, THE PATIENTS' NURSE "BELIEVES THIS MAY BE RELATED TO THE PATIENT'S AGITATION AND WITHDRAWAL SYMPTOMS." ADDITIONAL EVENT AND PATIENT INFORMATION WAS REQUESTED. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501992 ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 00827002064843

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention