MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 24"(60CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number M8702

Device Problems Detachment Of Device Component (1104); Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: did the needle fall into the patient? no was the needle retrieved in the same procedure? yes was additional tissue incision required to retrieve the needle? no the suture with the diameter issue is the same suture with the tangled thread, or is it the other suture? same 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.

Event Description

It was reported that during a cabg procedure on (b)(6) 2017, suture was used.It was reported that the needle of the suture popped off at the swege.The surgeon opined that one of the sutures was an 8-0 size instead of the 7-0 it should have been.Procedure was completed with suture from these first two packs and another pack of suture of the same product from a different lot code.There were no patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Evaluation: a representative sample was returned for analysis.This product code is double armed and required four strands per packet.Upon visual inspection, no defects were found on the package.The sample was opened the swage and attachment area were as expected and the needles/sutures were found correctly placed.The sutures were dispensed without problems and examined along the strand, no defects and/or damaged were found.The sutures were measured in diameter and the met the finished goods requirements in minimum individual and average for this product code.In addition, the samples were tested by needle pull and met the finished goods requirement for this product code.Per the condition of the representative sample, no assembly error, incorrect component or performance pull off suture needle were found on the sample and the tested needles/suture combinations met the finished goods requirements.

• Brand Name: PROLENE SUTURE 24"(60CM) 7-0 BLU
• 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.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7142513
• MDR Text Key: 95743237
• Report Number: 2210968-2017-71917
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 10705031045774
• UDI-Public: 10705031045774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: M8702
• Device Lot Number: LGE147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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