MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30IN(75CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number F2435H

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

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.Additional information was requested and the following was obtained: what is the product quality issue? please provide specific complaint details.All the information are provided on the event description.A photo has been received for analysis.Note: event reported in 2210968-2020-00786.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was noted incoherent information between labels on f2435 shuttles for the same product code.Different needles were noted on the label.There were no adverse patient consequences reported.No additional information was available.

Manufacturer Narrative

Date sent to the fda: 03/04/2020.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified additional h-3 summary: actual: one open sample of product with lot number pbq075 was received for evaluation.During the visual inspection of the sample, the printing image on the tip needle shows a unfilled ink triangle.Due to this condition a further investigation was performed, and the graphics used is correct according to manufacturing dates and finished drawing.The graphic used is version 10.In addition, the needle rmc assigned to this lot number is (fs032224f) needle sales type fs-3, 3/8 circle, cutting edge reverse.Also, the printing image on the paper lid shows the point type on the lot number pbq075.The version of the product code is release in our system and is sold in different countries.According to visual inspection and further investigation result the printing information is correct in the sample photo: one picture was provided for analysis.Upon visual inspection of the photo, the printing image on the tip needle, of the lot number pbq075 show a unfilled ink triangle.However, no conclusion could be reach as the sample was not returned for analysis at that time.

• Brand Name: ETHILON SUTURE 30IN(75CM) 4-0 BLK
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9641421
• MDR Text Key: 195237358
• Report Number: 2210968-2020-00787
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031239036
• UDI-Public: 10705031239036
• 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
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: F2435H
• Device Catalogue Number: F2435H
• Device Lot Number: PBQ075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 02/05/2020
• Patient Sequence Number: 1