MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SILI UMST TR

Catalog Number	URO170816S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the foley catheter was placed at 11:00 am in the patient who was in labor and had epidural.Per report, the foley catheter was noted draining well until 01:44 pm when the patient was taken to the operating room for caesarian section after it was noted that her cervical dilation was arrested potentially from bladder distention.The foley catheter reportedly was "milked" and it started to drain.It was reported that there was no specific issue identified as potential reason for foley catheter not draining the patient's bladder.The patient did not require a foley catheter re-insertion after the incident.There was no serious injury reported related to the event.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was returned for evaluation and the reported issue of a non-draining foley catheter was not confirmed.It was noted that the catheter had been working properly until the patient was in the operating room, and that "milking" the catheter allowed for drainage.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a patient with foley catheter in place, who was in labor, developed bladder distention and arrest of cervical dilation.

• Common Device Name: TTL1LYR 16FR10ML 100%SILI UMST TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7641547
• Report Number: 1417592-2018-00062
• Device Sequence Number: 16189010
• Product Code: OHR
• UDI-Device Identifier: 10889942126828
• UDI-Public: 10889942126828
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: Nurse
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: URO170816S
• Device Lot Number: 17ZM7516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• 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: 06/27/2018
• 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; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 69