MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYRTR 16FR10ML100%SIL UMS SNP

Catalog Number	URO175816S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, on (b)(6) 2026, "the rn went to insert a foley post epidural placement.Upon opening the foley kit, the rn noticed that the sterile water syringe was not full and the black top of the syringe was missing.".
Additional Manufacturer Narrative
According to the facility, on (b)(6), "the rn went to insert a foley post epidural placement.Upon opening the foley kit, the rn noticed that the sterile water syringe was not full and the black top of the syringe was missing.No black top was found inside the foley packaging and the sterile water syringe was only filled to ~3cc with the plunger of syringe not pushed down".The facility stated no patient was harmed and no medical intervention was necessary.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on (b)(6)2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: 1LYRTR 16FR10ML100%SIL UMS SNP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21208246
• Report Number: 1417592-2025-00034
• Device Sequence Number: 11741388
• Product Code: OHR
• UDI-Device Identifier: 40193489988308
• UDI-Public: 40193489988308
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 01/22/2025

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 Expiration Date: 09/30/2025
• Device Catalogue Number: URO175816S
• Device Lot Number: 24JBN887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown