MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J740D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device not returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: could you please confirm how many devices present the issue (pull off suture needle)? the sales rep reported 2 devices.No further information will be provided.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2020 and suture was used.During the procedure, the suture got detached from the needle.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: VCL CT BRD VIO 8X18IN 0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11068704
• Report Number: 2210968-2020-10271
• Device Sequence Number: 13751310
• Product Code: GAM
• UDI-Device Identifier: 10705031042636
• UDI-Public: 10705031042636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/09/2020

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: 07/31/2025
• Device Model Number: J740D
• Device Catalogue Number: J740D
• Device Lot Number: QJMHZB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/23/2020
• Patient Sequence Number: 1