MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J334H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number ap1733, and no non conformances / manufacturing irregularities were identified.(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.Additional information was requested and the following was obtained: what is the procedure date? don¿t know.What was the initial procedure? don¿t know.Could you please confirm what was broken (suture or needle)? please clarify needle.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, at the time of use, the needle broke when the skin was sutured.There were no adverse patient consequences.No additional information was provided.

• Brand Name: VCL CT BRD VIO 27IN 0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12384306
• Report Number: 2210968-2021-07782
• Device Sequence Number: 4648625
• Product Code: GAM
• UDI-Device Identifier: 10705031038936
• UDI-Public: 10705031038936
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: 12/31/2025
• Device Model Number: J334H
• Device Catalogue Number: J334H
• Device Lot Number: AP1733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/30/2021
• Patient Sequence Number: 1