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

Catalog Number	DYND11523
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Syringe filled with air, not water.
Additional Manufacturer Narrative
It was reported that "syringe to fill balloon with air, not water".The customer reported that this same patient "had to have 3 foleys replaced" in total.The customer reported there was no serious injury, medical intervention, or follow-up care required related to the reported incident.No additional information is available at this time.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Common Device Name: 2-LAYER TRAY,FOLEY,100% SIL,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: 23830366
• Report Number: 1417592-2025-00725
• Device Sequence Number: 13000582
• Product Code: OHR
• UDI-Device Identifier: 10884389497296
• UDI-Public: 10884389497296
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/17/2025

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?: Yes
• Device Catalogue Number: DYND11523
• Device Lot Number: 25GBJ327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 113 KG