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

Catalog Number	J493G
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
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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 via: my complaint was 5.0 vicryl, claim number (b)(4).(b)(6.I spoke with agent id 702368962 fc.Intake warranty coordinator.Johnson and johnson, med tech., mentor.I am not sure where these other claim numbers come from.Please inform me of the next step is to solve this issue.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 provide product code for vicryl 5.0 - lot number.- procedure name and date.- please provide the product code: - do you have any photos available for visual analysis? - please provide the source or name of person providing answers to follow-up questions:.
Event or Problem Description
It was reported that a patient underwent an unknown surgery in 2023 and suture was used.During the procedure, it was reported by the account contact that suture separation from the needle from the thread.It happens when the needle is going through the hub.It has happened about 3 or 4 times.No adverse patient consequences were reported.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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.(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.Corrected information: h6 type of investigation (b17- device not returned).
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/21/2023.The following additional information was received: (b)(6); product code j493g; product functional family vicryl ethicon; serial number (b)(6); procedure mini facelift/upper bilateral blepharoplasty; date unknown; please let me know if you need further information.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
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18004254
• Report Number: 2210968-2023-08155
• Device Sequence Number: 17802863
• Product Code: GAM
• UDI-Device Identifier: 10705031040496
• UDI-Public: 10705031040496
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2023

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: J493G
• Device Lot Number: TAMCAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 11/28/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/21/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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