MAUDE Adverse Event Report: COVIDIEN MONOJECT; SYRINGE, PISTON

Model Number	8881512258
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 6/7/17.An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer reports particulate was discovered in a 12 ml ll syringe.

• Brand Name: MONOJECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana 92173 ; MX 92173
• MDR Report Key: 6619856
• Report Number: 9612030-2017-05095
• Device Sequence Number: 19022598
• Product Code: FMF
• UDI-Device Identifier: 30884521010974
• UDI-Public: 30884521010974
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2017

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: 8881512258
• Device Catalogue Number: 8881512258
• Device Lot Number: 634980064X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/07/2017
• Patient Sequence Number: 1