MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; TRAY CAUTI TEMP SENS MF 14FR 10ML SAFE

Model Number	URO170814TSQ
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, a patient was admitted to the hospital with the foley catheter in place and it was found to be 'leaking at the insertion site'.The customer reported after being unsuccessful with trouble shooting techniques an additional catheter was required to be inserted.The customer reported there was no patient harm related to this incident.Sample is not available 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.
Event or Problem Description
According to the customer, a patient was admitted to the hospital with the foley catheter in place and it was found to be 'leaking at the insertion site'.The customer reported after being unsuccessful with trouble shooting techniques an additional catheter was required to be inserted.

• Brand Name: Medline
• Common Device Name: TRAY CAUTI TEMP SENS MF 14FR 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: 16211045
• Report Number: 1417592-2023-00029
• Device Sequence Number: 19871704
• Product Code: OHR
• UDI-Device Identifier: 10193489723496
• UDI-Public: 10193489723496
• 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): 01/19/2023

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: URO170814TSQ
• Device Catalogue Number: URO170814TSQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/19/2023
• 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