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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. RETINAL PACK

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MEDLINE INDUSTRIES INC. RETINAL PACK Back to Search Results
Catalog Number DYNJ44962D
Device Problem Use of Device Problem (1670)
Patient Problem Eye Injury (1845)
Event Date 10/23/2020
Event Type  Injury  
Manufacturer Narrative

It was reported that the patient was undergoing a vitrectomy and when the doctor was injecting balanced salt solution (bss) with the tuberculosis (tb) syringe it was difficult to press the plunger requiring force which caused a hole in the patient's retina. Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer. Samples were received for evaluation however the customer reported issue was not confirmed and no root cause could be determined. Due to the reported incident, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.

 
Event Description

It was reported that the syringe plunger was difficult to press down which led to the end user applying additional force causing a hole in the patient's retina.

 
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Type of DeviceRETINAL PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093-2753
MDR Report Key10907437
MDR Text Key218659540
Report Number1423395-2020-00038
Device Sequence Number1
Product Code OJK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 11/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDYNJ44962D
Device LOT Number20FBD641
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/30/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/26/2020 Patient Sequence Number: 1
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