MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 2-0 D/A V-5 + PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number SX54H

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  malfunction  

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.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.How many devices were involved in this single procedure? do you have any pictures for analysis? what is the lot number? device return follow up.Additional information was requested and the following was obtained: could you please explain what is the exact problem with the sutures? the issue is with the pledgets.Pledget was damaged and not in the exact size what is the issue the diameter or the length? there is no issue with the length or diameter.Note: events reported in 2210968-2020-04618, 2210968-2020-04619, and 2210968-2020-04620.

Event Description

It was reported that a patient underwent a valve replacement procedure on (b)(6) 2020 and suture was used.During the procedure, it was noted that the pledget in the suture was not in the exact size as per the description.The surgeon did not use the device after it was opened.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: 07/06/2020.Additional information was requested and the following was obtained: how many devices were involved in this single procedure? 3 devices involved in this single procedure.What is the lot number? pdh602.Device return follow up.¿ the device was not available, since due to the current situation they are not holding any of the materials used in a surgery.

Manufacturer Narrative

(b)(4).Additional information: h4, h6.A manufacturing record evaluation was performed for the finished device batch pdh602, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: EB EXC GRN 36IN 2-0 D/A V-5 + PLGT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10162174
• MDR Text Key: 195393813
• Report Number: 2210968-2020-04620
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 10705031050587
• UDI-Public: 10705031050587
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: SX54H
• Device Catalogue Number: SX54H
• Device Lot Number: PDH602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Patient Sequence Number: 1