BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 7428313 · Received April 13, 2018

    Report

    Report Number
    1820334-2018-00940
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    March 21, 2018
    Report Date
    June 12, 2018
    Manufacturer
    COOK INC
    Product Code
    GBO
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION: A REVIEW OF THE DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. THE CUSTOMER COULD NOT CONFIRM THE LOT NUMBER, HOWEVER, STATED THE DEVICE MAY BE FROM LOT 843539 OR LOT 8427627. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. A DATABASE REVIEW REVEALED ONE OTHER POSSIBLE COMPLAINT ON THESE LOTS FROM THE SAME CUSTOMER FOR THE SAME FAILURE MODE. 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. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER QUALITY ENGINEERING RISK ASSESSMENT, THERE IS NO FURTHER ACTIONS REQUIRED AT THIS TIME. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. H3 OTHER TEXT : BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION: A REVIEW OF THE DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. THE CUSTOMER COULD NOT CONFIRM THE LOT NUMBER, HOWEVER, STATED THE DEVICE MAY BE FROM LOT 843539 OR LOT 8427627. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. A DATABASE REVIEW REVEALED ONE OTHER POSSIBLE COMPLAINT ON THESE LOTS FROM THE SAME CUSTOMER FOR THE SAME FAILURE MODE. 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. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER QUALITY ENGINEERING RISK ASSESSMENT, THERE IS NO FURTHER ACTIONS REQUIRED AT THIS TIME. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT CAME BACK TO THE HOSPITAL TEN DAYS AFTER A NEPHROSTOMY DUE TO THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKING AT THE PROXIMAL CONNECTION. AS REPORTED, THE DEVICE WAS REPLACED AND THIS INCIDENT DID NOT CAUSE HARM TO THE PATIENT. THIS MEDWATCH IS ASSOCIATED WITH 1820334-2018-00941 AS THE FACILITY REPORTED THE SAME TYPE OF INCIDENT OCCURRED WITH TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270566 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention