MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,100%SILICONE,18FR,10ML,LF

Catalog Number	DYND11503
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility "the incident occurred post-operatively on the same day the patient underwent a prostatectomy.While experiencing abdominal pressure, the patient was sitting on the edge of the bed and subsequently laid back.At that moment, the foley catheter dislodged and fell out.Upon inspection, it was observed that the balloon was deflated, and a plastic component was missing from the catheter assembly".Per the facility "following the event, the urologist was required to intervene and perform a cystoscopic procedure to retrieve the missing plastic piece from the patient's bladder.A new foley catheter was then re inserted".No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, 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 "the incident occurred post-operatively on the same day the patient underwent a prostatectomy.While experiencing abdominal pressure, the patient was sitting on the edge of the bed and subsequently laid back.At that moment, the foley catheter dislodged and fell out.
Additional Manufacturer Narrative
Updated: b4, d4, d9, g3, g6, h2, h3, h6.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,18FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22095753
• Report Number: 1417592-2025-00257
• Device Sequence Number: 12729383
• Product Code: EZL
• UDI-Device Identifier: 10080196845460
• UDI-Public: 10080196845460
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 08/13/2025

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: DYND11503
• Device Lot Number: 592240811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown