MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER,FOLEY,3-WAY,16FR 30ML,100PERCES

Catalog Number	DYND11572H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 12/19/2024, "when we tried to use the irrigation during the surgery it wouldn't accept any fluid via cysto tubing and when we tried it manually, with a syringe, it took more pressure than it should.We ended up replacing the foley".The facility stated that there does not appear to be associated harm.A sample is not available 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 or Problem Description
According to the facility on 12/19/2024, "when we tried to use the irrigation during the surgery it wouldn't accept any fluid via cysto tubing and when we tried it manually, with a syringe, it took more pressure than it should.We ended up replacing the foley.".

• Common Device Name: CATHETER,FOLEY,3-WAY,16FR 30ML,100PERCES
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21240802
• Report Number: 1417592-2025-00039
• Device Sequence Number: 11673086
• Product Code: EZL
• UDI-Device Identifier: 10884389119853
• UDI-Public: 10884389119853
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 01/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYND11572H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/27/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown