MAUDE Adverse Event Report: COVIDIEN SURGIPRO; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	SP5682G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Suture broke while tying.A 4-0 surgipro ii on a p-12 needle.

• Brand Name: SURGIPRO
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield, MA 02048
• MDR Report Key: 5510017
• Report Number: 5510017
• Device Sequence Number: 10157512
• Product Code: GAW
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/10/2016
• Report Date (Section F): 03/10/2016

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: No Information
• Device Catalogue Number: SP5682G
• Device Lot Number: D5F1149X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 03/10/2016