MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYR TRY 16FR 10ML 100% SILI UM SNAP

Catalog Number	URO175816
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿slip tip sprung broke off in inflation part.¿.
Additional Manufacturer Narrative
The customer reported that, on (b)(6) 2023, the rn was preparing to insert a foley catheter for a surgical procedure, attached the syringe to the catheter, and the tip of the syringe broke off in the port of the catheter; the foley catheter was not used on the patient and a new kit was obtained, with no injury or medical intervention required but a delay to obtain a new kit.Medline quality received a photograph documenting the reported issue, and a retrospective review of the past 6 months preceding the reported issue revealed two additional complaints of broken syringe tips with respect to uro175816.Medline¿s investigations confirmed that the breaking of syringe tips is attributable to a physical weakness at the connection point between the syringe tip and the syringe barrel.The issue was described as random, but not widespread, and medline stated that manufacturing partners proposed a design change to the syringe and that comparative testing from the manufacturer indicates an increase in tip strength based on the design changes.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: 1LYR TRY 16FR 10ML 100% SILI UM SNAP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50714214
• Report Number: 1417592-2026-35683
• Device Sequence Number: 16126374
• Product Code: OHR
• UDI-Device Identifier: 40193489987462
• UDI-Public: 40193489987462
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: URO175816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown