BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUN-L-XL/24

    MDR report key: 6476930 · Received April 10, 2017

    Report

    Report Number
    1316297-2017-00001
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    March 1, 2017
    Report Date
    April 10, 2017
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K954584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EPIMED SENT A SECOND EMAIL TO THE ACCOUNT REPRESENTATIVE ON APRIL 24, 2017, IN AN EFFORT TO ACQUIRE ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT. THE ACCOUNT REPRESENTATIVE RESPONDED ON APRIL 25, 2017, STATING THAT THERE WAS NO NEW INFORMATION TO REPORT FROM THE ACCOUNT IN QUESTION.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, DR. (B)(6), PHYSICIAN AT (B)(6), REPORTED THAT HE HAD A BROKEN CATHETER. NO OTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. ON MARCH 30, 2017, THE PRODUCT ARRIVED AT (B)(4) FACILITY FOR EXAMINATION. THE REPORTING ACCOUNT RETURNED APPROXIMATELY 16.5CM OF THE CATHETER. THIS FRAGMENT WAS FROM THE DISTAL END OF THE CATHETER TRACKING 16.5CM TOWARDS THE CATHETER'S PROXIMAL END. THE SHEAR APPEARED TO TRACK SLIGHTLY FROM THE CATHETER'S PROXIMAL END TO THE CATHETER'S DISTAL END. THIS IS INDICATIVE OF THE ACCOUNT RETRACTING THE CATHETER WHILE THE NEEDLE WAS STILL IN PLACE. ON APRIL 6, (B)(4) EMAILED (B)(4), THEIR (B)(4) SALES CONSULTANT, IN AN ATTEMPT TO GAIN MORE INFORMATION REGARDING THE REPORTED EVENT. AS OF APRIL 10, NO ADDITIONAL INFORMATION HAD BEEN PROVIDED. THE COMPLAINT REPORT STATED THAT NO PATIENT INFORMATION IS PROVIDED BY DOCTORS OR NURSES IN (B)(4) DUE TO PRIVACY DATA PROTECTION LAWS. BASED ON THE PORTION OF THE CATHETER THAT WAS RETURNED TO (B)(4) , IT IS BELIEVED THAT NONE OF THE CATHETER WAS RETAINED WITHIN THE PATIENT. BATCH HISTORY RECORDS WERE REVIEWED FOR ANY ANOMALIES WITHIN THE LOT; HOWEVER, NONE WERE FOUND. (B)(4) WILL CONTINUE TO FOLLOW UP WITH (B)(4) IN ORDER TO GAIN ADDITIONAL INFORMATION. THIS REPORT WILL BE UPDATED ONCE NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, DR. (B)(6), PHYSICIAN AT (B)(6), REPORTED THAT HE HAD A BROKEN CATHETER. NO OTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. ON MARCH 30, 2017, THE PRODUCT ARRIVED AT (B)(4) FACILITY FOR EXAMINATION. THE REPORTING ACCOUNT RETURNED APPROXIMATELY 16.5CM OF THE CATHETER. THIS FRAGMENT WAS FROM THE DISTAL END OF THE CATHETER TRACKING 16.5CM TOWARDS THE CATHETER'S PROXIMAL END. THE SHEAR APPEARED TO TRACK SLIGHTLY FROM THE CATHETER'S PROXIMAL END TO THE CATHETER'S DISTAL END. THIS IS INDICATIVE OF THE ACCOUNT RETRACTING THE CATHETER WHILE THE NEEDLE WAS STILL IN PLACE. ON APRIL 6, (B)(4) EMAILED (B)(4), THEIR (B)(4) SALES CONSULTANT, IN AN ATTEMPT TO GAIN MORE INFORMATION REGARDING THE REPORTED EVENT. AS OF APRIL 10, NO ADDITIONAL INFORMATION HAD BEEN PROVIDED. THE COMPLAINT REPORT STATED THAT NO PATIENT INFORMATION IS PROVIDED BY DOCTORS OR NURSES IN (B)(4) DUE TO PRIVACY DATA PROTECTION LAWS. BASED ON THE PORTION OF THE CATHETER THAT WAS RETURNED TO (B)(4) , IT IS BELIEVED THAT NONE OF THE CATHETER WAS RETAINED WITHIN THE PATIENT. BATCH HISTORY RECORDS WERE REVIEWED FOR ANY ANOMALIES WITHIN THE LOT; HOWEVER, NONE WERE FOUND. (B)(4) WILL CONTINUE TO FOLLOW UP WITH (B)(4) IN ORDER TO GAIN ADDITIONAL INFORMATION. THIS REPORT WILL BE UPDATED ONCE NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260223 TUN-L-XL/24 TUN-L-XL/24 BSO EPIMED INTERNATIONAL INC. A-EP-089 11427578

    Patients

    Seq Age Sex Outcome Treatment
    1