MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; TRAY CAUTI TEMP SENS MF 16FR 10ML SAFE

Model Number	URO170816TSQ
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2023, the foley began to leak around the balloon and when the balloon was checked, urine came out of the balloon.
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023, the foley began to leak around the balloon and when the balloon was checked, urine came out of the balloon.The customer reported an additional catheter was required to be inserted.The customer reported there was no serious injury or additional medical intervention required related to the reported incident.Sample was requested for return evaluation.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.

• Brand Name: Medline
• Common Device Name: TRAY CAUTI TEMP SENS MF 16FR 10ML SAFE
• 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: 16808559
• Report Number: 1417592-2023-00187
• Device Sequence Number: 6034119
• Product Code: OHR
• UDI-Device Identifier: 10193489723427
• UDI-Public: 10193489723427
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/25/2023

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: Health Professional
• Device Model Number: URO170816TSQ
• Device Catalogue Number: URO170816TSQ
• Device Lot Number: 5922203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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