MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG VELOSORB FAST; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	CV-1215
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, when on the percutaneous tissue, just before suturing using a running stitch by the surgeon, the device's thread broke and the needle was detached.The patient's outcome was unknown.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
This report is filed in error and riverpoint would be filing all subsequent communications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VELOSORB FAST
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7365982
• Report Number: 1219930-2018-01625
• Device Sequence Number: 1950193
• Product Code: GAM
• UDI-Device Identifier: 20884521150888
• UDI-Public: 20884521150888
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2018

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: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: CV-1215
• Device Catalogue Number: CV-1215
• Device Lot Number: 16011321X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 05/28/2018; 05/28/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 06/12/2018; 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1