MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTL1LYR 16FR10ML 100%SIL TMPST TR

Catalog Number URO170816TS

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported by the customer contact that on 10/23/23, "foley placed by surgeon was out of the patient and on the floor".It was reported that a second foley was placed.A "pinprick" hole was noted to be found.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.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 placed by surgeon was out of the patient and on the floor".

• Type of Device: TTL1LYR 16FR10ML 100%SIL TMPST TR
• 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: 18208870
• MDR Text Key: 328999248
• Report Number: 1417592-2023-00464
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10889942127955
• UDI-Public: 10889942127955
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: URO170816TS
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/30/2023
• 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