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

Catalog Number	VCP352H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass graft procedure on an unknown date in 2023 and suture was used.The doctor found out the suture thread detached from the needle when he was suturing with it.The procedure was successfully completed and there were no adverse patient consequences.No further information was provided.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.The returned sample revealed that it was received one needle-suture piece that pertains to product code vcp352h was received for evaluation.Upon visual inspection, the returned sample was evaluated.The swage and attachment area was noted to be as expected.Marks on the body and the edge needle that appears to be by a surgical instrument could be observed.The needle was noted with the suture to be still attached to the barrel hole.The end of the suture was observed to be cut possibly caused by a surgical instrument.Overall, no needle pull-off was observed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• Brand Name: VCL+ VIO 27IN 0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17956428
• Report Number: 2210968-2023-07923
• Device Sequence Number: 5119036
• Product Code: GAM
• UDI-Device Identifier: 10705031052635
• UDI-Public: 10705031052635
• Combination Product (Y/N): Y
• Initial Reporter Country: HK
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: VCP352H
• Device Lot Number: SK2ACE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown