MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 54"(135CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	D6819
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient an unknown procedure on an unknown date and suture was used.The needle prematurely popped off while suturing.This occurred after several passes.The case was completed with another device of the same product code.There were no patient consequences reported.

• Brand Name: VICRYL SUTURE 54"(135CM) 1 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8579495
• Report Number: 2210968-2019-81034
• Device Sequence Number: 14001274
• Product Code: GAM
• UDI-Device Identifier: 10705031026834
• UDI-Public: 10705031026834
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

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 Catalogue Number: D6819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1