MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY,IRRIGATION,PISTON SYRINGE,60ML,STRL

Catalog Number	DYND20302
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	07/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on (b)(6) 2025 the syringe was being used to irrigate a patient's cbi catheter and the "rubber component in the syringe became dislodged" causing the clinician's "eyes" to get "splashed with bodily fluids / blood containing fluids".The customer reported that the employee required follow up with employee health service, had their labs drawn, but there was no report of intervention related to the issue.The customer reported the procedure was able to be completed.No additional details are available related to the customer reported issue.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, or follow-up care associated with the reported problem/issue.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 for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that on (b)(6) 2025 the syringe was being used to irrigate a patient's cbi catheter and the "rubber component in the syringe became dislodged" causing the clinician's "eyes" to get "splashed with bodily fluids / blood containing fluids".

• Common Device Name: TRAY,IRRIGATION,PISTON SYRINGE,60ML,STRL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22835531
• Report Number: 1417592-2025-00392
• Device Sequence Number: 10200127
• Product Code: KYZ
• UDI-Device Identifier: 10080196031801
• UDI-Public: 10080196031801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/18/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYND20302
• Device Lot Number: 0332501A146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• 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