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

Model Number URO170814TSQ

Device Problem Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/21/2023

Event Type  Injury  

Event Description

According to the facility urine was leaking around the catheter which required the staff to remove the catheter and replaced it with a new catheter.

Manufacturer Narrative

According to the facility urine was leaking around the catheter which required the staff to remove the catheter and replaced it with a new catheter.No additional information is available at this time.The sample was returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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
• Type of Device: TRAY CAUTI TEMP SENS MF 14FR 10ML SAFE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16930050
• MDR Text Key: 315195610
• Report Number: 1417592-2023-00213
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10193489723496
• UDI-Public: 10193489723496
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2023

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
• Device Operator: Health Professional
• Device Model Number: URO170814TSQ
• Device Catalogue Number: URO170814TSQ
• Device Lot Number: 592211004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other