MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYRINGE,TOOMEY,IRRIGATION,70CC,STERILE

Catalog Number	DYND20323
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, "due to the detachable nature of the tip, as well as the poor seal between the piston and syringe, it is impossible to generate enough negative pressure to adequately irrigate.In addition, due to the detachable tip, there have been multiple instances where that tip became detached during irrigation, causing spillage or dangerous spray of bloody urine".The facility stated they repeated irrigations using a different brand of catheter-tipped syringe.The facility stated they are not aware of any instance where a patient was taken to the or for a clot evacuation due to an inability to clear clot with these syringes.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.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
According to the facility, "due to the detachable nature of the tip, as well as the poor seal between the piston and syringe, it is impossible to generate enough negative pressure to adequately irrigate.In addition, due to the detachable tip, there have been multiple instances where that tip became detached during irrigation, causing spillage or dangerous spray of bloody urine".

• Common Device Name: SYRINGE,TOOMEY,IRRIGATION,70CC,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21067723
• Report Number: 1417592-2025-00004
• Device Sequence Number: 8409395
• Product Code: KYZ
• UDI-Device Identifier: 40884389106304
• UDI-Public: 40884389106304
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 01/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYND20323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 01/03/2025
• 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
• Patient Sex: Unknown