MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 3-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J332H
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2024 and suture was used.A problem with the thread was encountered.Doctors are complaining that the vicryl 3-0 is coming differently in some envelopes, appearing to have a thinner diameter than others from the same box and lot.The threads were not used for this reason.It was reported that the same problem was encountered in december with the same lot.There was no patient consequence.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Attempts are being made to obtain 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.Please clarify: in how many procedures did the doctors encounter a thinner suture diameter than others from the same box and lot? please provide event dates for additional procedures.Attempts are being made to retrieve the device.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.H6 component code: g07002 ¿ device not returned.Related events captured via: 2210968-2024-00405.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Investigation summary: the product was returned to ethicon for evaluation.Thirty-three representative unopened samples and six open undispensed samples that pertain to product code j332h were received for analysis.As per the sampling plan, a visual inspection was performed on thirteen samples and the six opened samples.The needle sutures were dispensed without problems and examined, no anomalies or defects were observed.Also, the sutures were measured in the federal gauge, and the results met the requirements.In addition, a photo was provided, and it shows two suturing needles, one of which appears thinner than the other.The event described could not be confirmed as no anomalies were noted.As part of the 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 manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: VCL CT BRD VIO 27IN 3-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19386384
• Report Number: 2210968-2024-05560
• Device Sequence Number: 4071504
• Product Code: GAM
• UDI-Device Identifier: 10705031038899
• UDI-Public: 10705031038899
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: J332H
• Device Lot Number: AU9667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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