MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYRTR 16FR10MLC100%SIL UM SNP

Catalog Number	URO175816C
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on (b)(6)2024 the balloon for a foley catheter deflated requiring a new catheter to be inserted.Per the facility the patient was not injured.The sample is not available for evaluation.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.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.
Event or Problem Description
According to the facility on (b)(6) 2024 the balloon for a foley catheter deflated requiring a new catheter to be inserted.
Additional Manufacturer Narrative
Updated: b3, g6, h2.

• Common Device Name: 1LYRTR 16FR10MLC100%SIL UM SNP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20924225
• Report Number: 1417592-2024-01032
• Device Sequence Number: 5093127
• Product Code: OHR
• UDI-Device Identifier: 40193489988728
• UDI-Public: 40193489988728
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 06/17/2025

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?: No
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: URO175816C
• Device Lot Number: 24EBN699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 06/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown