MAUDE Adverse Event Report: COVIDIEN MAGELLAN; SYRINGE, PISTON

Model Number	8881882812
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 7/12/17.An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer states liquid residue in the syringe.

• Brand Name: MAGELLAN
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701 9062
• MDR Report Key: 6706132
• Report Number: 1915484-2017-05037
• Device Sequence Number: 16403737
• Product Code: FMF
• UDI-Device Identifier: 10884521005921
• UDI-Public: 10884521005921
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2017

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: 8881882812
• Device Catalogue Number: 8881882812
• Device Lot Number: 612434X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/12/2017
• Patient Sequence Number: 1