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	08/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During assembling prior to surgery, product broke.
Event or Problem Description
During assembling prior to surgery, product broke.

• Brand Name: ETHICON
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 7863990
• Report Number: 7863990
• Device Sequence Number: 1567572
• Product Code: FMF
• UDI-Device Identifier: 10705031007239
• UDI-Public: (01)10705031007239
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018
• Report Date (Section F): 08/23/2018

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: 6371339050
• Device Catalogue Number: 6371339050
• Device Lot Number: 180001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 137
• Date Report Sent to FDA: 08/23/2018