MAUDE Adverse Event Report: COVIDIEN MONOJECT; SYRINGE, PISTON

Model Number	8881511110
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 6/8/17.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 is stating that the safety sheath is coming off of the syringe when activating or is not locking/continuously twisting.
Additional Manufacturer Narrative
Submit date: 1/11/2018, an investigation of the reported condition was performed.A device history record (dhr) review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.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.The manufacturing site received one unpackaged sample with this customer report.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted.Shield extend, shield retract, shield locking torque, shield/collar spin, and shield detach testing was performed.The syringe met all the requirements of the testing.No issues were identified on the customer returned syringe samples.The unpackaged syringe sample was tested, and the safety shield device was activated and met the requirements.Determination of the potential root cause of safety shield issues on the syringe samples is hypothetical in nature due to the syringe passing the testing, potential contributing factors to safety shield issue is, but are not limited to: damage to the shield or collar locking and stop features during manufacturing and transport.Incorrect handling with malformation of the collar or shield or excessive torque to force the shield out of the locked position.Improper technique or not following instruction standard for use.Safety shield issues were not observed at the time of the reported incident.Preventive maintenance requirements are established for the tooling, mold machines, assembly machine, sensors and printing stations used in the manufacture of the barrel.Periodic inspections are conducted throughout the manufacturing process to ensure the requirements of the quality inspection standard are met.Following the review of the dhr and product trending results, the investigation concluded that the production of both lot and its product was found to be compliant with all manufacturing and quality regulations and requirements.Based on the information available and the investigation findings, a corrective and preventative action (capa) is not deemed necessary 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: 6623114
• Report Number: 1915484-2017-05032
• Device Sequence Number: 10786928
• Product Code: FMF
• UDI-Device Identifier: 10884521014930
• UDI-Public: 10884521014930
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/11/2018

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: 12/31/2021
• Device Model Number: 8881511110
• Device Catalogue Number: 8881511110
• Device Lot Number: 633430X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 01/11/2018
• Patient Sequence Number: 1