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

Model Number	7777850310
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 8/15/17.An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer reported broken hub.There was a leak of product between the syringe and the needle at the de-aeration time ¿deltoid 1¿/blue hub.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6795791
• Report Number: 1017768-2017-05115
• Device Sequence Number: 149924
• Product Code: FMI
• UDI-Device Identifier: 10884521155534
• UDI-Public: 10884521155534
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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: Other
• Device Model Number: 7777850310
• Device Catalogue Number: 7777850310
• Device Lot Number: 435669X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 12/01/2017
• Patient Sequence Number: 1