MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 0 S/A MO-4 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J701D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2022 and suture was used.During the procedure, suture got detached from the needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 05/26/2022.(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 have been 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.Additional information was requested, and the following was obtained via: when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling or during use on the patient)? please specify.Answer: needle popped off on first pass of suture through tissue.Please provide the lot number for j701d: answer: rmmkhj device return status: answer: i listed it as available and i'm waiting to receive the shipping boxes to send it in.Did the event occur during one or multiple patient procedures? answer: multiple patient procedures over two separate days.What is the total number of procedures? answer: unknown.At least 3.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Answer: not that i have reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/30/2022.H6 component code: g07002 no device return.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 8X18IN 0 S/A MO-4 CR
• Common Device Name: 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: 14518001
• Report Number: 2210968-2022-04099
• Device Sequence Number: 5628954
• Product Code: GAM
• UDI-Device Identifier: 10705031042322
• UDI-Public: 10705031042322
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: J701D
• Device Catalogue Number: J701D
• Device Lot Number: RMMKHJ
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 06/26/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown