MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 5-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number JP493G

Device Problems Material Separation (1562); Dull, Blunt (2407)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: (b)(6) 2023.H6 component code: g07002 - device not returned.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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.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? please clarify if the patient was affected by surgery: please provide the source or name of person providing answers to follow-up questions: 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.Related reports: 2210968-2023-08615.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.During the procedure, the first suture detached at the time of use.The second suture detached during the surgical procedure, the sharp part detached and it was not possible to cross patient's skin.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/4/2023.Additional information was requested, the following was obtained: was there any adverse consequence associated with the patient? no exist event adverse in the patient.Please clarify if the patient was affected by surgery: the patient had no consequences.Please provide the source or name of person providing answers to follow-up questions: (b)(6).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 UD 18IN 5-0 S/A P-3 PRM MP
• Type of Device: 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: 18085680
• MDR Text Key: 327548317
• Report Number: 2210968-2023-08616
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K022269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JP493G
• Device Lot Number: AT6570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1