MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 18FR10ML 100%SILI DB TRA

Catalog Number	URO170718
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient pulled out his foley catheter resulting in the catheter snapping in half and braking off inside the patient.As a result the patient required surgery (cystoscopy without incisions) and re-insertion of a new foley catheter.The foley catheter was in place for one day prior to the incident.The patient was transferred to the intensive care unit (icu) for observation and is currently being treated for a urinary tract infection (uti).The sample involved in the incident was not returned for evaluation however the customer did return photographs of the catheter involved and the customer reported issue of a torn catheter was confirmed.A root cause cannot be determined at this time.Due to the reported incident and need for surgical intervention, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient pulled his foley catheter out and pieces of the catheter broke off inside the patient requiring surgery and re-insertion of new foley catheter.

• Common Device Name: TTL1LYR 18FR10ML 100%SILI DB TRA
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7864117
• Report Number: 1417592-2018-00102
• Device Sequence Number: 11254537
• Product Code: OHR
• UDI-Device Identifier: 10888277866935
• UDI-Public: 10888277866935
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: URO170718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/11/2018
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 82