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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MONOJECT SYRINGE SYRINGE, PISTON

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COVIDIEN MONOJECT SYRINGE SYRINGE, PISTON Back to Search Results
Model Number 31G
Device Problems Delivered as Unsterile Product (1421); Failure to Deliver (2338); Dull, Blunt (2407)
Patient Problems Eye Injury (1845); Unspecified Infection (1930)
Event Date 05/02/2019
Event Type  Injury  
Event Description
Infection and ophthalmic injury from device. Compounded syringe needle was dull. Plunger unable to express product. Resulted in infection. Currently awaiting sensitivity results. Feel that this is not a sterile product and syringe isn't a proper delivery device. Outside room air can be drawn into the syringe and contaminate product since the plunger can freely move during shipping. The device should be individually sealed so that plunger can't move and draw in bacteria. Current package isn't sterile. The outside of the syringe should be sterile has fingerprints on it, so common bacteria can easily enter the product. When we contacted the mfr, they said they don't make this drug in syringes. (b)(6) in (b)(6) is the compounding mfr. Awaiting results. Fda safety report id# (b)(4).
 
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Brand NameMONOJECT SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
melbourne FL
MDR Report Key8599820
MDR Text Key144841873
Report NumberMW5086525
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 05/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number31G
Device Lot NumberNO LOT NUMBER ON SYRINGE
Was Device Available for Evaluation? No
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: 05/09/2019 Patient Sequence Number: 1
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