MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 45CM M1::USP5/0 SGLE ARMED C-2; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number XN668H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: location where laceration was performed? forehead.Was any additional tissue dissection or damaged due to searching for the needle? no.Any other patient adverse consequence? if yes, what medical/surgical intervention was provided.No.After the suture was performed an rx exam in order to find the needle.The exam had negative outcome.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

Event Description

It was reported that the patient underwent repair of laceration on 2018 and suture was used.During the procedure, the needle detached from the suture.The patient underwent an x-ray and it needle was not present in body.There were no patient consequences.

• Brand Name: ETHILON BLK 45CM M1::USP5/0 SGLE ARMED C-2
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; 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: 7412996
• MDR Text Key: 105314847
• Report Number: 2210968-2018-72045
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• 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
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: XN668H
• Device Lot Number: LAZ386
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2018
• Date Device Manufactured: 01/13/2017
• 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