MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY,1LYR 12FR 10ML 100% SIL URN MTR

Model Number	SYR120010
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the syringe leaked during use.No serious injury or adverse impact to a patient or a user was originally reported.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.No photo or sample were provided for evaluation.The reported problem/issue was unable to be reproduced or confirmed and a root cause was unable to be determined.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the syringe leaked during use.

• Common Device Name: TRAY,1LYR 12FR 10ML 100% SIL URN MTR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19046560
• Report Number: 1417592-2024-00416
• Device Sequence Number: 7279999
• Product Code: OHR
• UDI-Device Identifier: 40889942213482
• UDI-Public: 40889942213482
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SYR120010
• Device Catalogue Number: URO170812
• Device Lot Number: 23FBL611/ 23FBU288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/13/2024
• 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