MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TTLVENT 14FR10ML 100%SIL DB TR

Model Number	URO180714
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 a patient called after a surgical procedure that required a foley insertion, to report that when she urinated she pulled a "1.5 to 2 inch piece of plastic from her urethra".The customer reported prior to finding "the plastic" the patient was having intense pain.The customer reported a catheter was inserted on (b)(6) 2023 prior to surgery and removed on the same day.The customer reported the "staff and/or surgeon" followed up on the patient multiple times and there were "no further issues reported".The customer reported there was no serious injury or medical intervention required related to the reported incident.Sample was requested for return evaluation.No additional information is available.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2023 a patient called after a surgical procedure that required a foley insertion, to report that when she urinated she pulled a "1.5 to 2 inch piece of plastic from her urethra".
Additional Manufacturer Narrative
Investigation conclusions.

• Brand Name: MEDLINE
• Common Device Name: TTLVENT 14FR10ML 100%SIL DB TR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16974119
• Report Number: 1417592-2023-00227
• Device Sequence Number: 20457922
• Product Code: OHR
• UDI-Device Identifier: 10889942687077
• UDI-Public: 10889942687077
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: URO180714
• Device Catalogue Number: URO180714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown