MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 6-0 D/A S-14; SUTURE, ABSORBABLE, SYNTHETIC

Model Number J570G

Device Problems Break (1069); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.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.Was there any adverse consequence associated with the patient? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

Event Description

It was reported that a patient underwent a wound closure surgery on (b)(6) 2021 and suture was used.During the procedure, the needle tip was found to be blunt after entering the abdominal cavity.The suture also broke when knotting.The broken end of the suture was flocculent and the subcutaneous tissue could not be firmly sutured, affecting the suture quality.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 3/7/2022.H6 component code: g07002 no device return.Additional information was requested, the following was obtained: was there any adverse consequence associated with the patient? according to latest feedback from the sales, no consequence was caused.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.

• Brand Name: VCL CT BRD VIO 18IN 6-0 D/A S-14
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13416906
• MDR Text Key: 285224202
• Report Number: 2210968-2022-00773
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031041318
• UDI-Public: 10705031041318
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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
• Device Operator: Health Professional
• Device Model Number: J570G
• Device Catalogue Number: J570G
• Device Lot Number: REMPER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 02/11/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Male