MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18" (45CM) 6-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J489G
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported that the device had packaging issues.There was no sample received for analysis.Only a picture of the sample was received for analysis.Upon visual inspection of the picture, an opened foil of product code j489 lot# mez014 and a folder of product code j544 could be observed.However, no conclusion could be reach as the sample was not returned for analysis.
Event or Problem Description
It was reported that an animal underwent an unknown procedure on (b)(6) 2019 and suture was used.It was noted that the wrong suture was inside one pack of box of 12.Outside label says j489 and inside suture says j544.No additional information was provided.

• Brand Name: VICRYL SUTURE 18" (45CM) 6-0 UND
• 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: 8691279
• Report Number: 2210968-2019-82651
• Device Sequence Number: 13938396
• Product Code: GAM
• UDI-Device Identifier: 10705031040427
• UDI-Public: 10705031040427
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: 04/30/2023
• Device Catalogue Number: J489G
• Device Lot Number: MEZ014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/12/2019
• Patient Sequence Number: 1