MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; TTL1LYR 16FR10ML 100%SIL TMP TRAY

Model Number URO170816T

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer in (b)(6) 2023.A foley catheter had a "detached temperature probe".Due to this, the catheter was removed and replaced.No additional information is available at this time.The sample was returned for evaluation and a definitive root cause cannot be determined at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer in (b)(6) 2023.A foley catheter had a "detached temperature probe".Due to this, the catheter was removed and replaced.

• Brand Name: Medline
• Type of Device: TTL1LYR 16FR10ML 100%SIL TMP TRAY
• 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: 16627140
• MDR Text Key: 312116472
• Report Number: 1417592-2023-00141
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10888277866942
• UDI-Public: 10888277866942
• 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: 03/28/2023

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 Model Number: URO170816T
• Device Catalogue Number: URO170816T
• Device Lot Number: 592211106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/28/2023
• 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