MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYRTR 16FR10ML LATEX UM SNAP

Catalog Number	URO175216
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 2 malfunction events that occurred during q2 2023 ((b)(6) 2023).The account reported that two uro175216 water-filled syringes experienced syringe tip breakage during use.The affected devices were associated with lot numbers 22kbc616 and 23bbd534.The customer reported that the syringe tips broke off during use, requiring use of an alternate syringe to complete the procedure.No patient harm was reported, and no medical intervention was required.Samples were reported as available and were returned for evaluation.No patient age, weight, sex, race, or ethnicity information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 2 malfunction events that medline became aware of during q2 2023 ((b)(6) 2023).Associated tray lot numbers are 22kbc616 and 23bbd534.Two uro175216 snap secure 1-layer foley catheter trays, latex, urine meter, 16 fr, 10 ml were returned for evaluation following reports that the water syringe tip broke off during use.Medline quality received both returned products in their original packaging and used condition.Visual inspection and functional evaluation of the syringe components confirmed the reported defect.Examination of the returned samples identified broken syringe sample ports/tips, confirming the reported failure mode.Based on the complaint details and sample evaluation, the reported issue was confirmed.Investigation determined that this failure mode was a known issue associated with scar-00258.The identified root cause was physical weakness at the junction between the syringe tip and syringe barrel, which could result in breakage of the syringe tip during use.The manufacturing facility was notified of the issue, and the event was incorporated into ongoing corrective action and monitoring activities.A retrospective review identified no additional complaints involving broken syringe tips for the associated lot numbers 22kbc616 and 23bbd534.Replacement product was issued to the customer as a follow-up action.Of the events summarized, 2 devices were returned for evaluation.The devices were labeled for single use, and no devices were identified as reprocessed or reused.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: 1LYRTR 16FR10ML LATEX UM SNAP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869565
• Report Number: 1417592-2026-48883
• Device Sequence Number: 9380259
• Product Code: OHR
• UDI-Device Identifier: 40193489987394
• UDI-Public: 40193489987394
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: URO175216
• 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: 05/24/2023
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown