MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; 1LYR 16FR 10ML 100%SILI UM TRAY

Model Number	DYND160816
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023, "a registered nurse noted leaking when moving the urometer bag from sterile container to hang on bed".Per the facility, "urometer bag was cracked in multiple places and the patient had an additional foley catheter placed".The sample is not available to be returned 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) 2023, "a registered nurse noted leaking when moving the urometer bag from sterile container to hang on bed".

• Brand Name: Medline
• Common Device Name: 1LYR 16FR 10ML 100%SILI UM TRAY
• 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: 16229544
• Report Number: 1417592-2023-00033
• Device Sequence Number: 5542905
• Product Code: OHR
• UDI-Device Identifier: 10884389286296
• UDI-Public: 10884389286296
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/23/2023

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: DYND160816
• Device Catalogue Number: DYND160816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/23/2023
• 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