MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE; 1LYRTR 16FR10ML 100%SILI SNAP

Catalog Number	URO175716
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported "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 balloon 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".Additionally it was reported "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." it has been determined that the reported event caused or contributed to serious injury, 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
"foley cath noted to be partially inflated, foley balloon noted to only be inflated with 7ml of fluid not 10 ml.".

• Brand Name: MEDLINE
• Common Device Name: 1LYRTR 16FR10ML 100%SILI SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24818480
• Report Number: 1417592-2026-00387
• Device Sequence Number: 15841835
• Product Code: OHR
• UDI-Device Identifier: 10193489987423
• UDI-Public: 10193489987423
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 04/08/2026

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: URO175716
• Device Lot Number: 25IBP544
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female