MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CATHETER,FOLEY,SILI-ELAST,LTX,16FR,10ML

Catalog Number	DYND11756
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during routine indwelling foley catheter exchange old catheter balloon would not deflate.Luer lock syringe used would be pulled back and canal to balloon would visibly deflate with no liquid return.Catheter remained anchored and could not be removed.".
Additional Manufacturer Narrative
The customer reported that during a routine indwelling foley catheter exchange using the 16fr10ml catheter, the old catheter balloon would not deflate, the catheter remained anchored and could not be removed, and after 2 hrs the catheter balloon was deflated on own and foley had come out; no injury, no medical intervention, no follow-up was reported.Medline quality did not receive a sample nor photographs of the reported product, and a retrospective review of the past 6 months preceding the reported issue revealed 0 additional complaints of foley balloon deflation issues with respect to this product.The issue is unconfirmed, as no samples nor photographs were made available to review.Based on the description of the issue involving the 16fr latex foley catheter, some possible root causes may be, but are not limited to, deflation procedure, or an unverified product defect; there are currently no known trends for this product and medline quality will continue to monitor for the issue through weekly complaint meetings and monthly trending analysis.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,16FR,10ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50589099
• Report Number: 1417592-2026-31533
• Device Sequence Number: 9442227
• Product Code: EZL
• UDI-Device Identifier: 40080196726524
• UDI-Public: 40080196726524
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: DYND11756
• Was Device Available for Evaluation?: Yes
• 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: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown