MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18"(45CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J765D
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Is this complaint related to suture diameter or is the issue related to an incorrect component in the package? do you have a photo?.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2017 and suture was used.It was found that there was a suture with the thickness of 2-0 in the package before use.There were no adverse consequences to the patient.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was requested and the following was obtained: is this complaint related to suture diameter or is the issue related to an incorrect component in the package? this complaint is related to an incorrect component in the package.Do you have a photo? no photo was provided from the hp.No further information will be provided.

• Brand Name: VICRYL SUTURE 18"(45CM) 1 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7046267
• Report Number: 2210968-2017-71342
• Device Sequence Number: 16653494
• Product Code: GAM
• UDI-Device Identifier: 10705031042834
• UDI-Public: 10705031042834
• Combination Product (Y/N): N
• 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): 10/25/2017

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: 06/30/2022
• Device Catalogue Number: J765D
• Device Lot Number: LHZ203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1