MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYRTR 16FR10ML SILV UM SNAP

Catalog Number	URO175516
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Unintended Deflation (4061)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer contact on (b)(6) 2026, "foley catheter was inserted into patient.Once urine return was seen, catheter was advanced and balloon was inflated.Resistance was not felt.When cleaning up the used foley kit and moving the foley bag around, the foley catheter slid out of the patient with the balloon deflated".
Additional Manufacturer Narrative
According to the customer contact on (b)(6) 2026, "foley catheter was inserted into patient.Once urine return was seen, catheter was advanced and balloon was inflated.Resistance was not felt.When cleaning up the used foley kit and moving the foley bag around, the foley catheter slid out of the patient with the balloon deflated.Upon further inspection, a tear was seen in the silicon material where the balloon had been.A second foley catheter was placed using the same sterile technique where blood-tinged urine was seen.At the end of the case the foley was checked.The pt was very dehydrated, so not much urine was seen, but what little urine there was it was still blood-tinged, though without clot.This satisfied the surgeon enough that no real damage had been caused, so the foley was discontinued".Customer contact stated, "surgeon followed up with patient later the same day and the following day.The following day, the surgeon said the patient was voiding without difficulty, without pain, and in larger amounts.They were still having blood-tinged urine, but it was less so than the day before".It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.

• Brand Name: MEDLINE
• Common Device Name: 1LYRTR 16FR10ML SILV UM SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24820735
• Report Number: 1417592-2026-00389
• Device Sequence Number: 12268824
• Product Code: OHR
• UDI-Device Identifier: 10193489988949
• UDI-Public: 10193489988949
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: URO175516
• Device Lot Number: 25EBL164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 90 KG