MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTLVENT 16FR10ML 100%SIL DB TR

Catalog Number	URO180716
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on 04/09/2024 the foley balloon did not inflate requiring an additional catheter to be placed.The customer reported there was "no injury" to the patient as a result of the reported incident.The customer reported there was no serious injury, medical intervention, or follow-up care needed related to the reported incident.No additional information is available at this time.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 04/09/2024 the foley balloon did not inflate requiring an additional catheter to be placed.

• Common Device Name: TTLVENT 16FR10ML 100%SIL DB TR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19271954
• Report Number: 1417592-2024-00591
• Device Sequence Number: 20671465
• Product Code: OHR
• UDI-Device Identifier: 40889942687085
• UDI-Public: 40889942687085
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 05/08/2024

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: Health Professional
• Device Catalogue Number: URO180716
• Device Lot Number: 23LBH339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 79 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG