MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYRTR 16FR10ML LATEX DB SNAP

Catalog Number URO175116

Device Problem Leak/Splash (1354)

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

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2023 "the patient's foley catheter would not drain urine causing the foley catheter to be exchanged due to issues".Per the facility the foley catheter was irrigated due to continued issues with occlusion causing urinary retention.The device was requested for 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.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

According to the facility on (b)(6) 2023 "the patient's foley catheter would not drain urine causing the foley catheter to be exchanged due to issues".

• Type of Device: 1LYRTR 16FR10ML LATEX DB SNAP
• 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: 17703699
• MDR Text Key: 322893022
• Report Number: 1417592-2023-00365
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10193489987294
• UDI-Public: 10193489987294
• 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: 09/07/2023

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 Catalogue Number: URO175116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/07/2023
• 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