MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CATHETER,FOLEY,SILI-ELAST,LTX,14FR,10ML

Catalog Number	DYND11754
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "after medication was removed, attempted to deflate foley balloon to remove catheter but was unable to deflate due to clog.".
Additional Manufacturer Narrative
The customer reported that the foley catheter was inserted for med instillation with 1 hour dwell time and, after medication was removed, the foley balloon was unable to deflate due to clog; the incident did not cause patient injury and the procedure was able to be completed.Visual assessment of the received samples revealed no abnormalities or defects, measurement of the catheter dimensions met the specified product criteria, and functional assessment was conducted by injecting 10 ml of water into the catheters¿ inflation port, with the balloons then deflated using the inflation syringe without issue.The reported issue of deflation failure could not be verified based on visual and functional assessment of the received samples, and functional testing revealed no defects nor abnormalities.The root cause could not be identified, and the complaint¿s cause code was updated to "unconfirmed defect: not confirmed with received sample." there were no reports of death, serious injury, medical intervention, or follow up care.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,14FR,10ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50618637
• Report Number: 1417592-2026-32746
• Device Sequence Number: 10542362
• Product Code: EZL
• UDI-Device Identifier: 10080196726516
• UDI-Public: 10080196726516
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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
• Device Catalogue Number: DYND11754
• Device Lot Number: 59225010049
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown