MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTLVENT 14FR10ML 100%SIL UM TR

Catalog Number	URO180814
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a patient required a foley catheter exchange after it was noted that urine was leaking from the vent material of the urine-meter drainage system.Reportedly, the incident was noted within less than 24 hours of the foley catheter being placed in the patient.The foley catheter was discontinued and a new foley catheter system was inserted.There was no reported impact to the patient.There was no serious injury or follow-up care reported related to the event.Due to the reported event and need for foley catheter re-insertion, this medwatch is being filed.The reported issue of a leaking vent was verified through functional evaluation of the received sample.There is no definitive root cause for the leakage at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that patient required a foley catheter exchange after it was noted that urine was leaking through the vent material of the urine meter drainage system.

• Common Device Name: TTLVENT 14FR10ML 100%SIL UM TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8451587
• Report Number: 1417592-2019-00040
• Device Sequence Number: 3219117
• Product Code: OHR
• UDI-Device Identifier: 10889942687138
• UDI-Public: 10889942687138
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: URO180814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/26/2019
• 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