MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 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	12/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025, during balloon inflation of a foley catheter, extreme resistance was encountered, requiring more effort than usual.Inflation of the balloon outside of the body was attempted and the same resistance was observed.The nurse then proceeded to inflate the balloon in the bladder.Bleeding from the urethra was observed.The patient was sent to the hospital due to uncontrolled urethral hemorrhage and received a urology consult with bladder irrigation.The patient returned to baseline and continued to utilize a catheter.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) 2025, during balloon inflation of a foley catheter, extreme resistance was encountered, requiring more effort than usual.Inflation of the balloon outside of the body was attempted and the same resistance was observed.The nurse then proceeded to inflate the balloon in the bladder.Bleeding from the urethra was observed.The patient was sent to the hospital due to uncontrolled urethral hemorrhage and received a urology consult with bladder irrigation.The patient returned to baseline and continued to utilize a catheter.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,14FR,30ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24438747
• Report Number: 1417592-2026-00148
• Device Sequence Number: 16043348
• Product Code: EZL
• UDI-Device Identifier: 10080196726578
• UDI-Public: 10080196726578
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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
• Operator of Device: Health Professional
• 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: 02/24/2026
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 111 KG