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

Catalog Number	URO175216
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per report, "installation port on the side of the foley drainage tube disconnects when applying equashield.This results in the need to detach the drainage bag from the foley and reattach a new drainage bag before proceeding with installation of chemo into the bladder." it has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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 or Problem Description
Per report, "installation port on the side of the foley drainage tube disconnects when applying equashield.This results in the need to detach the drainage bag from the foley and reattach a new drainage bag before proceeding with installation of chemo into the bladder.".

• Brand Name: MEDLINE
• Common Device Name: 1LYRTR 16FR10ML LATEX UM SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25088337
• Report Number: 1417592-2026-00904
• Device Sequence Number: 18738987
• Product Code: PPB
• UDI-Device Identifier: 10193489987393
• UDI-Public: 10193489987393
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: URO175216
• Device Lot Number: 25HBS747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown