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

Model Number	DYND20302
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the piston irrigation syringe separated.
Additional Manufacturer Narrative
It was reported that the piston irrigation syringe separated.The separation occurred while pulling back on the syringe.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.A returned sample and a comparative sample from stock were used in the evaluation of the reported problem/issue.Dimensional analysis found that the diameter of the rubber grommet was slightly under the required specification by an average of approximately 0.25mm.A brief functional evaluation was done on the samples by simulating an environment where a great amount of suction was produced on the plunger.It was observed that during these conditions, the grommet would detach from the plunger and remain inside the barrel of the piston irrigation syringe.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.

• Common Device Name: 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: 18825618
• Report Number: 1417592-2024-00149
• Device Sequence Number: 7785740
• Product Code: KYZ
• UDI-Device Identifier: 40080196031802
• UDI-Public: 40080196031802
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 03/03/2024

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 Model Number: DYND20302
• Device Lot Number: 0331907A174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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