MAUDE Adverse Event Report: ETHICON INC. VCL CT SUT 12X18IN(45CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J104G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
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 a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2019 and suture was used.The suture was broken during use.There were no adverse consequences to the patient.

• Brand Name: VCL CT SUT 12X18IN(45CM) 3-0 VIO
• 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: 8591234
• Report Number: 2210968-2019-81170
• Device Sequence Number: 2065690
• Product Code: GAM
• UDI-Device Identifier: 10705031037823
• UDI-Public: 10705031037823
• 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
• Report Date (Section B): 04/14/2019

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 Catalogue Number: J104G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2019
• Initial Report FDA Received Date: 05/08/2019
• Patient Sequence Number: 1