MAUDE Adverse Event Report: COVIDIEN COVIDIEN MONOJECT; 12 ML SYRINGE

Lot Number	534884964X
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
A covidien monoject 12 ml syringe had some sort of brown contaminant on part of the plunger wall when it was removed from the packaging.The defect was found before it was used.It came from a 12ml pharmacy tray with luer-lock tip.

• Brand Name: COVIDIEN MONOJECT
• Common Device Name: 12 ML SYRINGE
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 5537510
• Report Number: MW5061361
• Device Sequence Number: 963321
• Product Code: FMF
• UDI-Device Identifier: 10884521010970
• UDI-Public: (01)10884521010970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 534884964X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1