MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1LYRTR ADD-A-CATH UMST SNAP

Catalog Number	URO175200S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, 11/16/2025 the "sample port [came off] of an add-a-cath" and a new "foley and add a cath kit was replaced." no additional information is available at this time.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.Product information included in complaint: lot: 25ebj223.Exp: 5/15/2026.Date of mfg: 11/30/2025.Lot: 25ebk059.Exp: 5/18/2026.Date of mfg: 11/30/2025.
Event or Problem Description
According to the customer, 11/16/2025 the "sample port [came off] of an add-a-cath" and a new "foley and add a cath kit was replaced.".

• Brand Name: MEDLINE
• Common Device Name: 1LYRTR ADD-A-CATH UMST SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23839412
• Report Number: 1417592-2025-00727
• Device Sequence Number: 9817191
• Product Code: OHR
• UDI-Device Identifier: 10193489987676
• UDI-Public: 10193489987676
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 12/18/2025

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 Expiration Date: 05/15/2026
• Device Catalogue Number: URO175200S
• Device Lot Number: 25EBJ223, 25EBK059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2025
• 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: 6 YR
• Patient Sex: Unknown