MAUDE Adverse Event Report: ETHICON INC. ETHICON; SYRINGE, PISTON

Model Number	6371339050
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Evicel would not draw up into the syringes.

• Brand Name: ETHICON
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): ETHICON INC.; route 22 west; po box 151; somerville NJ 08876
• MDR Report Key: 7475355
• Report Number: 7475355
• Device Sequence Number: 13734123
• Product Code: FMF
• UDI-Device Identifier: 10705031007239
• UDI-Public: (01)10705031007239
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2018
• Report Date (Section F): 04/24/2018

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: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: 6371339050
• Device Catalogue Number: 6371339050
• Device Lot Number: 170131 AND 1070132
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2018
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 96
• Date Report Sent to FDA: 04/24/2018