MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; FOLEY CATHETER KIT (EXCLUDES HIV TESTING)

Model Number	URO175716
Health Effect - Clinical Codes	Laceration(s) (1946); Perineal injury (4898)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Pt fully dilated, dr.[redacted] at bedside for bedside sono [sonogram] with sve [sterile vaginal examination].Upon provider exam, provider states she could feel the foley balloon cath at the edge of pt urethra and behind baby head and foley cath completely dislodged and cause extensive urethral trauma.Rn at bedside with dr.[redacted].Foley cath noted to be partially inflated, foley ballon noted to only be inflated with 7ml of fluid not 10 ml (no leaking noted on foley cath upon examination).Pressure apply to urethra by dr.[redacted], dr.[redacted] and dr.[redacted] at bedside for assessment and pt straight cath before pushing and urology team involved after pt delivered.Pt pushed for 10 min and only had a 1st degree laceration.Unknown if product was defective.Foley catheter placed with 10ml in the balloon.Foley catheter was expelled through the urethra with balloon inflated.Volume of balloon was checked after expulsion and had 7ml in balloon.Prior to the expulsion of the foley catheter, the patient was in labor and her cervix fully dilated to 10cm.Other info from catheter packaging: uro175716, (b)(4), exp:2027-04-30.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: FOLEY CATHETER KIT (EXCLUDES HIV TESTING)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 24604448
• Report Number: 24604448
• Device Sequence Number: 15709987
• Product Code: PPB
• UDI-Device Identifier: 10193489987423
• UDI-Public: (01)10193489987423
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2026
• Report Date (Section F): 03/10/2026

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 Model Number: URO175716
• Device Catalogue Number: URO175716
• Device Lot Number: 25IBP544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/10/2026