MAUDE Adverse Event Report: ETHICON INC. MONOCRYL POLIGLECAPRONE 25 SUTURE; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number XNY3218E

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: please clarify when the needle separated from the thread (while in the package, during removal from package, during use on patient) a: first suture at first bite on patient.2nd and 3rd at removal from package.How many sutures presented the issue during the procedure? a: they tested three from that box.Opened another box which worked as normal for them.

Event Description

It was reported that a patient underwent an underwent an unknown procedure in 2018 and suture was used.During the procedure, the needle loosened from the thread.Another like device was used to complete the procedure with no adverse patient consequences.Additional information has been requested.

• Brand Name: MONOCRYL POLIGLECAPRONE 25 SUTURE
• 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.-UK; simpson parkway; kirkton campus; livingston ; UK
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7618997
• MDR Text Key: 111657972
• Report Number: 2210968-2018-73577
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: XNY3218E
• Device Lot Number: LA7BCGN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/25/2018
• Date Device Manufactured: 01/01/2017
• 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