MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 1663H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

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.When did the needle pull off (while in the package / during dispensing / during preparation / during use)? did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? 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 the patient underwent a vascular procedure in (b)(6) 2017 and suture was used for wound closure.During the procedure, the suture from the needle.Suture from a different lot was used to complete the procedure.There were no patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: (b)(4) 2018.The actual device was returned for evaluation.During the visual inspection of detached needle (1), the swage and attachment area were as expected.The barrel hole of the needle was examined under 20x magnification and no suture remnant was noted and slightly marks were noted on the body needle.The suture was not received for evaluation to determine the assignable cause.No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: ETHILON SUTURE 18"(45CM) 3-0 BLK
• 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.; 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: 7266981
• MDR Text Key: 100006685
• Report Number: 2210968-2018-70838
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031001732
• UDI-Public: 10705031001732
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

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: 1663H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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