MAUDE Adverse Event Report: COVIDIEN MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850110
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 9/15/17.An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer reports that air is being drawn into the syringe whilst obtaining samples.This affects the quality of the sample resulting in the patient having to have another venepuncture to obtain a second blood sample.

• Brand Name: MAGELLAN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 e international speedway; deland FL 32724 8707
• MDR Report Key: 6869405
• Report Number: 1017768-2017-05137
• Device Sequence Number: 1408849
• Product Code: FMI
• UDI-Device Identifier: 20884521000510
• UDI-Public: 20884521000510
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2017

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 Model Number: 8881850110
• Device Catalogue Number: 8881850110
• Device Lot Number: 635759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 09/15/2017
• Patient Sequence Number: 1