MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 2-LAYER TRAY,FOLEY,100% SIL,16FR,10ML,LF

Catalog Number	DYND11519
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, a patient was undergoing a laparoscopic appendectomy.After induction of general anesthesia and patient positioning, the foley catheter from the sterile kit was opened the surgeon inserted the catheter into the urethra and attempted to inflate the balloon with 10 ml of sterile water supplied in the kit.No resistance was felt when the surgeon was drawing the catheter back and subsequently removed it from the patient.It was observed that the balloon had not inflated.The catheter tip showed no visible holes or fraying.A replacement foley catheter was inserted without issue.The product required replacement; however, no patient injury, no additional medical intervention, and no follow up care were required.The procedure was completed successfully.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 (b)(6) 2025, a patient was undergoing a laparoscopic appendectomy.After induction of general anesthesia and patient positioning, the foley catheter from the sterile kit was opened the surgeon inserted the catheter into the urethra and attempted to inflate the balloon with 10 ml of sterile water supplied in the kit.No resistance was felt when the surgeon was drawing the catheter back and subsequently removed it from the patient.It was observed that the balloon had not inflated.The catheter tip showed no visible holes or fraying.A replacement foley catheter was inserted without issue.The product required replacement: however, no patient injury, no additional medical intervention, and no follow up care were required.The procedure was completed successfully.

• Brand Name: MEDLINE
• Common Device Name: 2-LAYER TRAY,FOLEY,100% SIL,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24094909
• Report Number: 1417592-2026-00050
• Device Sequence Number: 18716111
• Product Code: OHR
• UDI-Device Identifier: 10080196809790
• UDI-Public: 10080196809790
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND11519
• Device Lot Number: 96925060001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 88 KG