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

Model Number DYNJ44922F

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2021

Event Type  malfunction  

Event Description

Patient was undergoing a tarsal strip of the lower eyelid and upon attempting to inject the eyelid the 30g ½" needle came away from the 3 ml luer lock syringe.

• Brand Name: MEDLINE BASIC EYE CUSTOM PACK
• Type of Device: EYE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11731652
• MDR Text Key: 247506869
• Report Number: 11731652
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ44922F
• Device Catalogue Number: DYNJ44922F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1