MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYR 16FR10ML 100%SIL TMP SAFE

Catalog Number URO170816TQ

Device Problem Insufficient Information (3190)

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

Event Date 03/30/2023

Event Type  malfunction  

Manufacturer Narrative

According to the customer on 3/30, there was "no urine output" from the foley catheter.Due to this, the foley was removed and a new catheter was placed.There was no injury or additional medical intervention reported related to the event.A 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

Catheter not draining.Additional catheter placed.

• Type of Device: 1LYR 16FR10ML 100%SIL TMP SAFE
• 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: 16907195
• MDR Text Key: 314954044
• Report Number: 1417592-2023-00210
• Device Sequence Number: 1
• Product Code: OHR
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: URO170816TQ
• Device Lot Number: 592210901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Date Manufacturer Received: 04/13/2023
• 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