MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CATHETER,FOLEY,SILI-ELAST,LTX,14FR,30ML

Catalog Number	DYND11774
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2026, the balloon was very difficult to inflate.It took a lot more effort than usual.The nurse attempted to inflate the balloon and met extreme resistance.They stopped and trialed inflating a balloon outside of the body and was still met with the same resistance.The nurse then proceeded to inflate it in the bladder.At this time, the resident began bleeding from the urethra.The issue was that the increased amount of force required to inflate the balloons skewed the nurse's judgement of whether the balloon was in the bladder or not.The bleeding resolved on its own.The resident returned back to baseline and is still utilizing a catheter.There was no further information.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, 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) 2026, the balloon was very difficult to inflate.It took a lot more effort than usual.The nurse attempted to inflate the balloon and met extreme resistance.

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,14FR,30ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 24447372
• Report Number: 1417592-2026-00153
• Device Sequence Number: 10448587
• Product Code: EZL
• UDI-Device Identifier: 10080196726578
• UDI-Public: 10080196726578
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/25/2026

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?: No
• Device Catalogue Number: DYND11774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 88 KG