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

Catalog Number 1215T

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2016

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.The photo of product upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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 if there was any issues with package, was there any hole, tear or puncture that compromises sterility? what do you mean by "packaging (thread) comes very close to the sealing edge"? was the seal open or incomplete due to the product (thread being caught in seal)? was there any issue noticed with assembly of the suture thread in the primary packaging that caused the issue reported? are there any samples available to be returned for evaluation? if yes, how many?.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date.It was noticed that the internal packaging thread comes very close to the sealing edge, leaving the material exposed when it is opened and not made sterile.It is unknown when the event occurred.There were no adverse consequences for the patient reported.Additional information has been requested.

Manufacturer Narrative

Event date - (b)(4) 2016.Additional information was requested and the following was obtained: event date: (b)(4) 2016 (dd/mm/yyyy).Procedure name: passage of central venous catheter.User name: not identified.Was observe any abnormality or deficiency in the suture before, during or after use in the patient - no.Some part / piece of needle fell into the patient - was it retrieve - no.Was there some serious injury to the patient - no.They opened a device of the same lot number to use.It was received a photo.It has not been possible to perform any dimensional analysis for defects reported, whereas the sample was not returned.

Manufacturer Narrative

Received opened empty secondary package.During the tests, the paper did not tear or separated from the adhesive in a wrongly way.Besides, the results for sealing test fully met the material specification.Therefore, it was not possible to identify the cause for the torn paper as showed in the envelope received.Received partially opened secondary package and one unopened paper folder.During the tests, the paper did not tear or separated from the adhesive in a wrongly way.Besides, the results for sealing test fully met the material specification.Therefore, it was not possible to identify the cause for the torn paper as showed in the envelope received.

• 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.-BRAZIL; rodovia presidente dutra, km 1; 54; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: darlene kyle ; 9082182792
• MDR Report Key: 6283270
• MDR Text Key: 65962646
• Report Number: 2210968-2017-30411
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 1215T
• Device Lot Number: AF0523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1