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

Model Number URO170816T

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

According to the customer contact, on (b)(6)2023 a catheter was placed during surgery and was "not draining appropriately".Due to this, the urine output was monitored frequently.Due to the lack of urine output, a new catheter was placed.No injury was reported related to the incident.The sample was requested to be 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.

Event Description

Foley catheter not draining requiring replacement.

• 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: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16816201
• MDR Text Key: 314020860
• Report Number: 1417592-2023-00190
• 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: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• 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: 22LBM41
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other