MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; CATHETER, UROLOGICAL

Model Number	DYND13508
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Red rubber catheter was placed in patient's tracheostomy stoma to maintain patency.The catheter became lodged in the left bronchus and was subsequently removed in or.

• Brand Name: MEDLINE
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7609368
• Report Number: 7609368
• Device Sequence Number: 184224
• Product Code: KOD
• UDI-Device Identifier: 10080196031139
• UDI-Public: (01)10080196031139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/11/2018
• Report Date (Section F): 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: DYND13508
• Device Catalogue Number: DYND13508
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 06/11/2018