MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTLVENT 16FR10ML 100%SIL UM TR

Catalog Number	URO180816
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported a patient had a prostatectomy on (b)(6) 2020.Patient was seen by physician as an outpatient (date unknown), due to complaints of no urine output and bladder distention.Reportedly, the catheter had clotted and disrupted the anastomosis.A drain was placed by interventional radiology (date unknown) and patient was re-admitted to the hospital for an ileus (date unknown).The sample was not returned for evaluation therefore a root cause could not be determined.There is no further information at this time.Due to the nature of the incident, medical intervention, and in abundance of caution, this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported a patient had a prostatectomy on (b)(6) 2020.Patient was seen by physician as an outpatient (date unknown), due to complaints of no urine output and bladder distention.Reportedly, the catheter had clotted and disrupted the anastomosis.A drain was placed by interventional radiology (date unknown) and patient was re-admitted to the hospital for an ileus (date unknown).

• Common Device Name: TTLVENT 16FR10ML 100%SIL UM TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10228391
• Report Number: 1417592-2020-00065
• Device Sequence Number: 13601951
• Product Code: EZL
• UDI-Device Identifier: 10889942687145
• UDI-Public: 10889942687145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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: URO180816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/03/2020
• 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: Hospitalization; Other; Required Intervention