MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TTL1LYR 14FR10ML 100%SIL TMP TRAY

Catalog Number URO170814T

Device Problem Material Integrity Problem (2978)

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

Event Date 08/28/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2023 the foley catheter needed to be replaced due to the sample port detaching during use.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.

Event Description

According to the facility on (b)(6) 2023 the foley catheter needed to be replaced due to the sample port detaching during use.

• Type of Device: TTL1LYR 14FR10ML 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: 17749540
• MDR Text Key: 323438894
• Report Number: 1417592-2023-00374
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10888277868335
• UDI-Public: 10888277868335
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: URO170814T
• Device Lot Number: 96922030008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Date Manufacturer Received: 08/28/2023
• 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