MAUDE Adverse Event Report: COVIDIEN MONOJECT; SYRINGE, PISTON

Model Number	8881560125
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer states that the syringe was leaking from the plunger.
Additional Manufacturer Narrative
A device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.Customer reports syringe was leaking.The manufacturing site did not receive any samples or photos for evaluation.Therefore, the reported issue could not be confirmed.Without a representative sample(s) being provided, a more complete investigation cannot be performed to the full extent and the reported condition cannot be confirmed.In addition, without sample, a root cause cannot be determined at this time.Inspectors routinely examine the product to ensure it meets aql sampling criteria.Some potential defects that are inspected for include, but are not limited to syringe barrel leak test, damaged product or components, flash which renders the unit non-functional, holes, splits, or cracks in barrel which permit leakage, incomplete or incorrect assembly of product or package, and excessive lubricant in syringe.Procedures and standard work instructions exist for the setup, operation, and maintenance of the molding machines, printers, and assembly machines.Cleaning and maintenance requirements are defined and implemented to ensure continuing process capability.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; 1222 sherwood rd; norfolk NE 68701 9062
• MDR Report Key: 6774284
• Report Number: 1915484-2017-05045
• Device Sequence Number: 1002840
• Product Code: FMF
• UDI-Device Identifier: 10884521012233
• UDI-Public: 10884521012233
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: Other
• Device Model Number: 8881560125
• Device Catalogue Number: 8881560125
• Device Lot Number: 614717X
• 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: 01/12/2018
• Patient Sequence Number: 1