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

Model Number URO170814T

Device Problem Material Integrity Problem (2978)

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

Event Date 03/06/2023

Event Type  Injury  

Event Description

According to the facility (b)(6) 2023 the sample port detached and "the rn removed the foley with the detached sample port and inserted a new foley catheter".

Manufacturer Narrative

According to the facility (b)(6) 2023 the sample port detached and "the rn removed the foley with the detached sample port and inserted a new foley catheter".Per the facility the patient was not harmed when this occurred.No additional information is available at this time.The sample has not been returned for evaluation 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.

Manufacturer Narrative

Device was returned for evaluation and root cause was determined to be compenent defect.

• Brand Name: MEDLINE
• 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: 16664876
• MDR Text Key: 312531977
• Report Number: 1417592-2023-00149
• 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,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: URO170814T
• Device Catalogue Number: URO170814T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2023
• 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