MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYRTR 14FR10ML 100%SILI SNAP

Catalog Number	URO175714
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, rn inserted a foley catheter following an epidural placement for a laboring patient.After placement, it was identified that urine was not advancing forward into the catheter extension tubing/urine drainage bag.Rn attempted to flush catheter and then assessed the connection line, and ultimately urine remained in stasis once it reached the end of the indwelling drain.The catheter was removed and a new catheter from a different lot number was used for replacement and drained properly.No report of any injury or medical intervention needed.The patient is "stable, no further issues related." 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, on (b)(6) 2026, rn inserted a foley catheter following an epidural placement for a laboring patient.After placement, it was identified that urine was not advancing forward into the catheter extension tubing/urine drainage bag.Rn attempted to flush catheter and then assessed the connection line, and ultimately urine remained in stasis once it reached the end of the indwelling drain.

• Brand Name: MEDLINE
• Common Device Name: 1LYRTR 14FR10ML 100%SILI SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; three lakes dr; northfield, IL 60093 ; 2173279112
• MDR Report Key: 24512498
• Report Number: 1417592-2026-00178
• Device Sequence Number: 21454220
• Product Code: OHR
• UDI-Device Identifier: 10193489987416
• UDI-Public: 10193489987416
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: URO175714
• Device Lot Number: 25KBM741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White