MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE; CATHETER,FOLEY,TEMP SENS,16FR 10ML,LF

Catalog Number	DYND110516
Medical Device Problem Codes	Inflation Problem (1310); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Foley catheter "slipped out" due to balloon not being inflated.
Additional Manufacturer Narrative
It was reported that the foley catheter "slipped out" due to the balloon not remaining inflated.Due to this, a new device was required.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.

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,TEMP SENS,16FR 10ML,LF
• 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: 24421447
• Report Number: 1417592-2026-00139
• Device Sequence Number: 10577277
• Product Code: EZL
• UDI-Device Identifier: 10884389122976
• UDI-Public: 10884389122976
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYND110516
• Device Lot Number: 59225082991
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown