MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BASIC EYE PACK

Catalog Number	DYNJ44922F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported to the manufacturer via a medwatch report filed by the end-user facility ((b)(4)) that a patient was undergoing a tarsal strip of the lower eyelid and upon attempting to inject the eyelid the 30g 1/2" needle came away from the 3ml luer lock syringe.The customer contact was unable to provide further incident details to the manufacturer.No additional details are available related to the customer reported issue.The sample is not available to be returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
A patient was undergoing a tarsal strip of the lower eyelid and upon attempting to inject the eyelid the 30g 1/2" needle came away from the 3ml luer lock syringe.

• Common Device Name: BASIC EYE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12514280
• Report Number: 1423395-2021-00043
• Device Sequence Number: 19780252
• Product Code: OJK
• UDI-Device Identifier: 10193489338188
• UDI-Public: 10193489338188
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ44922F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other