MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 12X18IN 3-0 NON NDL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J110T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # : (b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent an appendicitis surgery procedure on (b)(6) 2019 and suture was used.It was reported that the suture was broken during the surgery.Another like suture was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.

• Brand Name: VCL CT BRD UD 12X18IN 3-0 NON NDL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8923149
• Report Number: 2210968-2019-86009
• Device Sequence Number: 2548676
• Product Code: GAM
• UDI-Device Identifier: 10705031037977
• UDI-Public: 10705031037977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2004
• Device Catalogue Number: J110T
• Device Lot Number: MJ2415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2019
• Supplement Date Received by Manufacturer: 07/28/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 08/23/2019
• Patient Sequence Number: 1