MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 2OZ EAR ULCER SYRINGE IN PACK EYE

Model Number	DYNJ60113C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an ear ulcer syringe component was "defective.".
Additional Manufacturer Narrative
It was reported that an ear ulcer syringe component was "defective." 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 photo and physical sample were provided for evaluation.The sample was found to be partially split open along the seam where the two component molds joined, making it unusable.The root cause was determined to likely be an issue related to the component manufacturing process.Due to the reported syringe break, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Update made to d2 product information.
Event or Problem Description
It was reported than an ear ulcer syringe component was "defective.".

• Common Device Name: 2OZ EAR ULCER SYRINGE IN PACK EYE
• 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: 18763995
• Report Number: 1423395-2024-00047
• Device Sequence Number: 4387278
• Product Code: KYZ
• UDI-Device Identifier: 40195327177479
• UDI-Public: 40195327177479
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/22/2024
• 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: DYNJ60113C
• Device Lot Number: 23KMA686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/22/2024
• 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