MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 54IN 1 S/A CPX LP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	D6819
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).A manufacturing record evaluation was performed for the finished device lot number qkmede, and no non-conformances related to the reported complaint condition were identified.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to clarify the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the needle kept popping off the sutures.The surgery, date of surgery and event occurrence are unknown.Additional information has been requested.

• Brand Name: VCL CT BRD VIO 54IN 1 S/A CPX LP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11369304
• Report Number: 2210968-2021-01727
• Device Sequence Number: 858883
• Product Code: GAM
• UDI-Device Identifier: 10705031026834
• UDI-Public: 10705031026834
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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: 08/31/2025
• Device Model Number: D6819
• Device Catalogue Number: D6819
• Device Lot Number: QKMEDE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/23/2021
• Patient Sequence Number: 1