MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE,EAR/ULCER, 3 OZ, STERILE

Model Number	DYND70277
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the ear ulcer syringe was "hard to squeeze." 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.Two (2) samples were returned for evaluation.Functional comparison was conducted by squeezing both ear ulcer syringes in the coaxial and radial directions.The force required to fully compress the ear ulcer syringe for the sample from lot 48620040003 was larger than the sample from the other reported lot.A retained sample from lot 48620040003 was evaluated and it did not require a larger forces to fully compress.The reported problem/issue was confirmed.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) 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 = 96919080002.
Event or Problem Description
It was reported that the ear ulcer syringe was "hard to squeeze.".

• Common Device Name: SYRINGE,EAR/ULCER, 3 OZ, STERILE
• 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: 18954329
• Report Number: 1417592-2024-00371
• Device Sequence Number: 12532380
• Product Code: KYZ
• UDI-Device Identifier: 40080196862543
• UDI-Public: 40080196862543
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/21/2024

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: DYND70277
• Device Lot Number: 48620040003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 03/21/2024
• 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