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

Model Number	URO175216
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility there was an issue with a foley catheter balloon requiring an additional catheter to be placed.
Additional Manufacturer Narrative
According to the facility there was an issue with a foley catheter balloon requiring an additional catheter to be placed.No additional information is available at this time.The sample was returned and evaluated, however, at this time a definitive root cause could not be determined.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Common Device Name: 1LYRTR 16FR10ML LATEX UM SNAP
• 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: 16502040
• Report Number: 1417592-2023-00089
• Device Sequence Number: 17702304
• Product Code: OHR
• UDI-Device Identifier: 10193489987393
• UDI-Public: 10193489987393
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: URO175216
• Device Catalogue Number: URO175216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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