MAUDE Adverse Event Report: ETHICON, LLC PROLENE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	EPM8736
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly male patient presents for a coronary artery bypass grafting (cabg) times 2.While physician was suturing an anastomosis on the heart, the suture broke half way around.Packaging was saved, but not the suture.No harm to the patient.

• Brand Name: PROLENE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON, LLC; route 22 west, p.o. box 151; somerville NJ 08876
• MDR Report Key: 8859911
• Report Number: 8859911
• Device Sequence Number: 19317302
• Product Code: GAW
• UDI-Device Identifier: 30705031203673
• UDI-Public: (01)30705031203673
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/23/2019
• Report Date (Section F): 07/23/2019

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 Model Number: EPM8736
• Device Catalogue Number: EPM8736
• Device Lot Number: MEH216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 106
• Date Report Sent to FDA: 07/23/2019