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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN AVASTIN SYRINGE, PISTON

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UNKNOWN AVASTIN SYRINGE, PISTON Back to Search Results
Model Number SYRINGE
Device Problem Gas Leak (2946)
Patient Problem Blurred Vision (2137)
Event Date 07/19/2019
Event Type  Injury  
Event Description
Medication wasn't present in syringe. Injected air bubble with silicone oil into left eye. Vision complaint with your product (cloudy vision>72 hrs). Syringe should have contained 0. 05 ml of avastin and no oil. Pt received only oil and air. (b)(6). Fda safety report id # (b)(4).
 
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Brand NameAVASTIN SYRINGE, PISTON
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
UNKNOWN
MDR Report Key8838737
MDR Text Key152751097
Report NumberMW5088458
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYRINGE
Device Catalogue Number31 G
Device Lot Number1906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/26/2019 Patient Sequence Number: 1
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