MAUDE Adverse Event Report: COVIDIEN MONOJECT; SYRINGE, PISTON

Model Number	8881560141
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 9/5/17.An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer states that the lower tip is melting and cannot use any fluid.
Additional Manufacturer Narrative
A product analysis cannot be performed as samples were not returned to the manufacturing site.The device history record (dhr) for lot 713843x was reviewed.During the manufacturing of the syringe assemblies, (b)(6) syringes were visually inspected and (b)(6) syringes were physically tested with 0 defects recorded relating to this customer report.The device history record for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.If samples are returned the site can re-open the investigation and perform an analysis on the returned samples.Without samples the root cause cannot be identified.Potential contributing factors can include but are not limited to: pack/cool time during manufacturing were set outside of operating window incorrect material used during manufacturing plastiating was set outside of operating window damaged components jam or alignment, note of these were noted in the dhr review.Without samples the site is not able to perform an analysis on the reported condition therefor no formal investigation actions are being taken at this time.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: 6841458
• Report Number: 1915484-2017-05047
• Device Sequence Number: 18996460
• Product Code: FMF
• UDI-Device Identifier: 10884521012240
• UDI-Public: 10884521012240
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/01/2018

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 Expiration Date: 06/30/2022
• Device Model Number: 8881560141
• Device Catalogue Number: 8881560141
• Device Lot Number: 713843X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 03/01/2018
• Patient Sequence Number: 1