MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. MCKESSON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	S699GX
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During surgical procedure performed to excise a skin lesion from patient's forehead, there were repeated suture breakages.There were two occurrences of complete separations of needles from sutures.During the second occurrence, the needle could not be located.The patient was sent to x-ray with a marker placed in order to locate the needle.Patient was returned to the procedure room where the needle was located and removed without further incidence.

• Brand Name: MCKESSON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 100 exchange boulevard; glendale heights IL 60139
• MDR Report Key: 7185470
• Report Number: 7185470
• Device Sequence Number: 18850232
• Product Code: GAR
• UDI-Device Identifier: 20612479214532
• UDI-Public: (01)20612479214532
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/01/2018
• Report Date (Section F): 01/01/2018

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: 05/31/2022
• Device Model Number: S699GX
• Device Lot Number: D7E0086X
• Other Device ID Number: (17)220531
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Date Report to Manufacturer: 01/01/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT APPLICABLE.
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2018