MAUDE Adverse Event Report: COVIDIEN MONOJECT; SYRINGE, PISTON

Model Number	8881520665
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 07/18/17.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 reported that the syringes were leaking and they can not use them.
Additional Manufacturer Narrative
An investigation of the reported condition was performed.No samples were returned for evaluation.The product analysis cannot be performed as samples were not returned to manufacturing site.A lot number was provided to the site.The device history record (dhr) for lot was reviewed.The device history record (dhr) for the lot control indicates that the product and specification requirements were met with no non-conforming product identified relating to this customer report.Without samples the root cause cannot be identified.Possible causes for syringes leaking can me associated with a jam in the equipment that caused the non-cylindrical syringe barrels.Leak testing is performed on each cavity of molded syringe barrels at prescribed intervals during the production process.If problems were detected during processing, non-conforming product would be rejected.If samples are returned the site can re-open the investigation and perform an analysis on the returned samples.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: 6721316
• Report Number: 1915484-2017-05041
• Device Sequence Number: 18884689
• Product Code: FMF
• UDI-Device Identifier: 10884521012165
• UDI-Public: 10884521012165
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/09/2018

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: 8881520665
• Device Catalogue Number: 8881520665
• Device Lot Number: 626836X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 03/09/2018
• Patient Sequence Number: 1