MAUDE Adverse Event Report: ETHICON INC. MONOCRYL VIO 27IN USP2-0::D/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number A1H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.Additional information was requested and the following was obtained: did the needle fall into the patient? needle did not fall into patient.Was the needle retrieved during the same procedure? no need to retrieve needle.Was additional tissue incision required to retrieve the needle? needle came off the suture after being pulled through tissue.No additional incision was necessary.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke off of the needle.There were no adverse patient consequences reported.Additional information has been requested.

• Brand Name: MONOCRYL VIO 27IN USP2-0::D/A UR-6
• Type of Device: SUTURE, ABSORBABLE, 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: 7449780
• MDR Text Key: 106145768
• Report Number: 2210968-2018-72228
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K960653
• 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: 03/26/2018

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 Expiration Date: 08/31/2022
• Device Catalogue Number: A1H
• Device Lot Number: LKM084
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/22/2018
• Date Device Manufactured: 09/01/2017
• 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