MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18"(45CM) 5-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	D7649
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
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 while stocking the device at facility on an unknown date, it was noticed that the product listed online and product master the needle listed is a tf-4 but the product came with a different configuration: tf-5 needle.There was no patient involvement.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/14/2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Evaluation: there was no sample received for analysis.Only pictures of the sample were received for analysis.Upon visual inspection of the picture, a box of product with a needle description could be observed.According to the manufacturing record, the components of the product are correct.However, the information of the product at the ethicon web page isn't actualized as the description is for another needle.

• Brand Name: VICRYL SUTURE 18"(45CM) 5-0 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: 7946930
• Report Number: 2210968-2018-76407
• Device Sequence Number: 2337954
• Product Code: GAM
• UDI-Device Identifier: 10705031028159
• UDI-Public: 10705031028159
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: 10/31/2022
• Device Catalogue Number: D7649
• Device Lot Number: LM6425
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 12/14/2018
• Patient Sequence Number: 1