MAUDE Adverse Event Report: ETHICON INC. NYL BLK MONO; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 644H

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Please confirm what do you mean by "the code (b)(4) is registered as a 3/8 circle but above the "decoder suture" tool but above the packaging there is written 1/4c."? was it a package labelling issue? or error with changes /updates to packaging/design etc? was it noticed on the outer box or inner package? was the box opened to check if the components inside were correct as per register? when was this issue noticed? within j&j control or outside j&j control? was this discovered at the distributor or at a hospital or similar facility? is there an indication of how the product was distributed? is there any indication of the source? based on the packaging, is there any indication of which market the product may have come from? do you have any pictures of the package with this issue?.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2017 and suture was used.It was noted that the product code was registered as a 3/8 circle but above the "decoder suture" tool but above the packaging there is written 1/4c.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Pc(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional information was requested and the following was obtained: please confirm what do you mean by "the code 644h is registered as a 3/8 circle but above the "decoder suture" tool but above the packaging there is written 1/4c."? the distributed packaging reports the description of the curve of the needle 1/4 although in the past it was 3/8 as registered also in the marketing tool was it a package labelling issue? the needle curve is different (1/4 the one delivered, in the past it was 3/8 and this same 3/8 is reported onto the marketing material).Or error with changes /updates to packaging/design etc? was it noticed on the outer box or inner package? both was the box opened to check if the components inside were correct as per register? the device was opened by the surgeon that noticed the discrepancy when was this issue noticed? within (b)(4) or outside (b)(4)? into the hospital was this discovered at the distributor or at a hospital or similar facility? hospital is there an indication of how the product was distributed? unk is there any indication of the source? unk based on the packaging, is there any indication of which market the product may have come from? unk do you have any pictures of the package with this issue? yes, attached.

Manufacturer Narrative

Pc-(b)(4).No suture, needle or winding former were returned for evaluation to determine the assignable cause of the packaging - labeling identification; therefore, the reported failure could not be evaluated.

• Brand Name: NYL BLK MONO
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON, INC. SAN LORENZO; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7105455
• MDR Text Key: 95064997
• Report Number: 2210968-2017-71708
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 644H
• Device Lot Number: JHP091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2018
• Date Device Manufactured: 07/08/2015
• 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