MAUDE Adverse Event Report: COVIDIEN MONOJECT; NEEDLE, DENTAL

Model Number	8881401049
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 07/27/17.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer stated that there is a tremendous amount of leakage and the needle broke during a procedure.

• Brand Name: MONOJECT
• Common Device Name: NEEDLE, DENTAL
• Manufacturer (Section D): COVIDIEN; 2010 e international speedway; deland FL 32724 8707
• MDR Report Key: 6748138
• Report Number: 1017768-2017-05110
• Device Sequence Number: 210176
• Product Code: DZM
• UDI-Device Identifier: 10884521002807
• UDI-Public: 10884521002807
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/29/2017

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: Dentist
• Device Expiration Date: 01/30/2021
• Device Model Number: 8881401049
• Device Catalogue Number: 8881401049
• Device Lot Number: 603922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/27/2017
• Patient Sequence Number: 1