MAUDE Adverse Event Report: COVIDIEN MONOJECT; SYRINGE, PISTON

Model Number	8881512977
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 8/8/17.An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer reports leaking from bottom of the syringe.
Additional Manufacturer Narrative
An investigation of the reported condition was performed.There were no samples submitted with this complaint.The complaint shall be reopened if a sample is received.The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.The reported condition could not be confirmed because a sample was not returned from the customer.The manufacturing process was reviewed and determined that product was manufactured in accordance whit the specifications required under official documents.The non-conformance report history was reviewed for this failure mode, as result, no reports for similar issue were found.The process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOJECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana INDUS TRIA; MX INDUSTRIAL
• MDR Report Key: 6773518
• Report Number: 9612030-2017-05141
• Device Sequence Number: 149451
• Product Code: FMF
• UDI-Device Identifier: 30884521012107
• UDI-Public: 30884521012107
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 01/24/2018

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 Expiration Date: 03/31/2022
• Device Model Number: 8881512977
• Device Catalogue Number: 8881512977
• Device Lot Number: 708086464X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 01/24/2018
• Patient Sequence Number: 1