MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 54IN 0 NON NDL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J207G
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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 a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the nurse opened the suture and realized it was the right suture but wrong plastic cover put on it.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot mk6373, and no non-conformances were identified.Only a picture was received for analysis.Upon visual inspection of the picture, a foil of product code j207 with lot# mk673 and spool with two punched holes could be observed.This code use a reel with one hole.However, as the sample was not returned, we are unable to investigate further.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: VCL CT BRD VIO 54IN 0 NON NDL
• 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: 8846371
• Report Number: 2210968-2019-84925
• Device Sequence Number: 19399978
• Product Code: GAM
• UDI-Device Identifier: 10705031038158
• UDI-Public: 10705031038158
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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 Expiration Date: 08/31/2023
• Device Catalogue Number: J207G
• Device Lot Number: MK6373
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1