MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC TUN-L-XL/24; CATHETER

Model Number	A-EP-089
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per mdr report mw5077449, submitted by (b)(6) to the fda on may 24, 2018: pt had catheter placed for loa procedure (b)(6) 2017.Pt left (b)(6) with catheter secured for infusion at (b)(6) clinic next day (b)(6) 2017.Catheter removed (b)(6) 2017 in office.Per md pt c/o back issues since removal.Fb identified.Dates of use; (b)(6) 2017 - (b)(6) 2017.Diagnosis or reason for use: low back and left leg pain.M.Devices group, (b)(6).Epimed received a letter from the department of health and human services dated may 30, 2018.The letter was to notify epimed of an mdr that was filed by (b)(6) regarding a patient event where the catheter had been removed by the facility but the patient was reportedly still experiencing back pain.The voluntary event report (mw5077449) stated that the facility had located a foreign body within the patient.No additional information was reported to epimed regarding the user name, reporter name, specific facility location, contact information or actions to be taken by the reporting facility in response to the foreign body that was identified.
Event or Problem Description
Per mdr report mw5077449, submitted by (b)(6) to the fda on may 24, 2018: pt had catheter placed for loa procedure (b)(6) 2017.Pt left (b)(6) with catheter secured for infusion at (b)(6) clinic next day (b)(6) 2017.Catheter removed (b)(6) 2017 in office.Per md pt c/o back issues since removal.Fb identified.Dates of use; (b)(6) 2017 - (b)(6) 2017.Diagnosis or reason for use: low back and left leg pain.M.Devices group, (b)(6).

• Brand Name: TUN-L-XL/24
• Common Device Name: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• MDR Report Key: 7615729
• Report Number: 1316297-2018-00004
• Device Sequence Number: 2412253
• Product Code: BSO
• UDI-Device Identifier: 00818788021212
• UDI-Public: 00818788021212
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 12/31/2021
• Device Model Number: A-EP-089
• Device Catalogue Number: 155-2542
• Device Lot Number: 11427899
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other