MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE INDUSTRIES, INC.; 1LYRTR 14FR10ML100%SILI UMSNAP

Model Number	URO175814
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, a nurse was obtaining a sample from the urine collection port and the "whole port came off".Due to this, urine was leaking and the sterility of the system was lost.The customer reported, due to this the foley was replaced.The customer reported no injury to the patient.A sample was requested to be returned for evaluation.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
Sample port dislodged requiring foley catheter replacement.
Additional Manufacturer Narrative
Updated type of investigation and investigation conclusion based on information received.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: 1LYRTR 14FR10ML100%SILI UMSNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16979900
• Report Number: 1417592-2023-00229
• Device Sequence Number: 6537305
• Product Code: OHR
• UDI-Device Identifier: 10193489987454
• UDI-Public: 10193489987454
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 05/22/2023

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
• Device Model Number: URO175814
• Device Catalogue Number: URO175814
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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