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

Catalog Number DYNJ59172B

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Eye Injury (1845)

Event Date 08/04/2020

Event Type  Injury  

Event Description

Surgeon applied a 30 gauge cannula to a 3 ml bss syringe from the eye pack.When surgeon attempted to use on the patient's eye, the 30 gauge cannula tip became dislodged from the syringe prior to inserting it into the eye.Syringe and cannula discarded and replaced with new syringe and cannula.No harm to patient.Addendum 9/1/2020: case submitted to pa psrs as incident on (b)(6) 2020.After further review/information, during procedure dislodgement of cannula from syringe that entered the right eye caused an injury, which was found to be violation of posterior capsule and retinal tear.Patient needed return to surgery for pars plana vitrectomy, perfluoron c3f8 16% and laser.Fda safety report id# (b)(4).

• Brand Name: EYE PACK
• Type of Device: EYE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; northfield IL 60093
• MDR Report Key: 10534805
• MDR Text Key: 207160105
• Report Number: MW5096598
• Device Sequence Number: 1
• Product Code: OJK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ59172B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR