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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES, INC. EYE PACK EYE TRAY Back to Search Results
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).

 
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Brand NameEYE PACK
Type of DeviceEYE TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
northfield IL 60093
MDR Report Key10534805
MDR Text Key207160105
Report NumberMW5096598
Device Sequence Number1
Product Code OJK
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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 Received09/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDYNJ59172B
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/14/2020 Patient Sequence Number: 1
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