MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y732H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

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.

Event Description

It was reported that an animal underwent a surgical procedure on (b)(6) 2018 and suture was used.During the procedure, the needle popped off of the suture at the swage.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 2-0 VIO
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7241402
• MDR Text Key: 99359075
• Report Number: 2210968-2018-70661
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059528
• UDI-Public: 10705031059528
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: Y732H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/05/2018
• 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