MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1718

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.The photo of the product upon which this medwatch is based has been received, however, the evaluation of the photo is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: lot number involved - the lot no.Is klq 624.The picture is also attached in this e-mail.There¿s no picture of white suture at the moment.Photo of white suture - there¿s no picture of the white suture since it¿s being discarded by the customer.Please provide storage conditions of the suture - the product stored normally in the hospital stock in the room temperature 25 c.Was the product re-sterilized? - because the complaint product is being discarded by the customer.It¿s not re-sterilized.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and the suture was used.It was also reported that the product was stored normally in the hospital stock in the room temperature and was not re-sterilized.It was noticed that the suture was white instead of black as written on the package.

Manufacturer Narrative

An empty opened box, a sealed box and opened samples were return for analysis.During the visual inspection of the samples, no defects were found on the package the samples were opened and the needles were attached to the sutures.The channel area of the needle/suture was examined for visual inspection attribute defects and no attachment defects were noted.The sutures were dispensed and examined per appearance and color along of the strand and not defects were found.The information of the product code and the lot number, graphic on the label printed was correct.Also, the product returned matched with the description of the label.

Manufacturer Narrative

Only a picture of the sample was received.Upon visual inspection of the picture, a sample of product code w1718tm could be observed.The information of the product code and the lot number, graphic on the label printed was compared with thunderbird system and the information was correct.According to the picture and the information of the sample (lot#), no assembly - incorrect component issues were found.

• Brand Name: ETHILON NYLON SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6650256
• MDR Text Key: 77868184
• Report Number: 2210968-2017-32635
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: W1718
• Device Lot Number: KLQ624
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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