MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TTL1LYR ADD-A-CATH PEDS,UM,PERIWIPE TRAY

Catalog Number	URO170350A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿while rn was inserting a foley for the procedure, debris was noted to be in the sterile water provided in the medline add-a-cath.It was noticed prior to inflating the balloon and was replaced with sterile water from the omnicell and a new sterile syringe.¿.
Additional Manufacturer Narrative
It was reported that ¿while rn was inserting a foley for the procedure, debris was noted to be in the sterile water provided in the medline add-a-cath.It was noticed prior to inflating the balloon and was replaced with sterile water from the omnicell and a new sterile syringe.¿ 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.

• Brand Name: MEDLINE
• Common Device Name: TTL1LYR ADD-A-CATH PEDS,UM,PERIWIPE TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50952529
• Report Number: 1417592-2026-55173
• Device Sequence Number: 13369243
• Product Code: OHR
• UDI-Device Identifier: 10889942467143
• UDI-Public: 10889942467143
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: URO170350A
• Device Lot Number: 26EBH883
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2026
• 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
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female