MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE; CATHETER,FOLEY,100%SILICONE,16FR,10ML,LF

Catalog Number	DYND11502
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon of catheter deflated causing it to fall out.
Additional Manufacturer Narrative
It was reported that after the device was changed, the provider's office received a call that the device fell out with bleeding.The patient went to the er and it was noted that the balloon was deflated.The catheter was replaced.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained,.

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,100%SILICONE,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: 24131674
• Report Number: 1417592-2026-00061
• Device Sequence Number: 20175999
• Product Code: EZL
• UDI-Device Identifier: 10884389034538
• UDI-Public: 10884389034538
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K082815
• 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): 01/21/2026

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
• Device Catalogue Number: DYND11502
• Device Lot Number: 59223102786
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 39 KG