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

Catalog Number	URO180816
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that on (b)(6) 2020, patient had prostatectomy procedure, discharged home with a jp drain and urinary catheter.Patient experienced large urine leak from the catheter at home.Followed-up with md (date unknown), catheter changed and ct scan completed to confirm placement.Patient again discharged home from clinic to be admitted to unity point-rock island hospital (date unknown).It was reported cultures were positive for blood in both the urine and jp drain.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 that on (b)(6) 2020, patient had prostatectomy procedure, discharged home with a jp drain and urinary catheter.Patient experienced large urine leak from the catheter at home.Followed-up with md (date unknown), catheter changed and ct scan completed to confirm placement.Patient again discharged home from clinic to be admitted to unity point-rock island hospital (date unknown).It was reported cultures were (b)(6) for blood in both the urine and jp drain.

• Common Device Name: TTLVENT 16FR10ML 100%SIL UM TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10230751
• Report Number: 1417592-2020-00066
• Device Sequence Number: 18981319
• 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): 07/03/2020

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; Required Intervention