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

Model Number DYND20302

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the piston irrigation syringe "sprayed" when it was inserted.According to the reporting facility, the device did not fit or flush a three-way stopcock and that it leaked around the plunger.No serious injury or adverse impact to a patient or to 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 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.Additional product lot reported = 96921070001.

Event Description

It was reported that the piston irrigation syringe "sprayed" when it was inserted.

• Type of Device: TRAY,IRRIGATION,PISTON SYRINGE,60ML,STRL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18954156
• MDR Text Key: 339087653
• Report Number: 1417592-2024-00332
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 40080196031802
• UDI-Public: 40080196031802
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYND20302
• Device Lot Number: 0332106A221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other