MAUDE Adverse Event Report: ETHICON INC. GUT PLAIN SUTURE 27"(70CM) 2-0 UND; SUTURE, ABSORBABLE, NATURAL

Catalog Number N863H

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Lot # ? do you have any pictures of package or box? is there an indication of how the product was distributed? is there any indication of the source? was another type of scanner used, to attempt reading the labels? what type of bar code is being scanned? do you think there were any changes /updates to packaging/design etc?.

Event Description

It was reported that prior to a procedure, a discrepancy between the inside package and the suture box was noticed.The suture is a 2-0 suture with a ct-3 needle but when the barcode on the package is scanned, it shows that the suture is a 2-0 with an fn needle.No patient involvement occurred.Additional information has been requested.

• Brand Name: GUT PLAIN SUTURE 27"(70CM) 2-0 UND
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7266715
• MDR Text Key: 100139036
• Report Number: 2210968-2018-70834
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: N863H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1