MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J464G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cyst excision on (b)(6) 2022 and suture was used.Three out of six sutures used so far have broken-the needle came off.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: pc- (b)(4) component code: (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.Additional information was requested, and the following was obtained: the needle pulled off the suture all 3 times.Please provide the date, and procedure name of the additional event.Please indicate how many needles broke during each procedure 3/24/22 and excision of basal cell carcinoma and 2 sutures were broken 3/30/22- cyst excision and 1 suture was broken.Was there any adverse consequence associated with the patient? no.When was the suture broke-the needle came off (in the package, during removal from package, during handling or during use on the patient)? please specify during use n the patient could you please clarify how many sutures are broken? 3.Could you please clarify how many needles came off? 3.Did the event occur during one or multiple patient procedures? multiple- 2 different patients.What is the total number of procedures? 2.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No.Please provide the lot number: rcmamu.Device return status: i do not have the broken sutures to return as they are in my sharps bin.I can however send the remaining box of sutures.How would you like me to proceed? 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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/7/2022.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 18IN 4-0 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; avenida de las torres 7125; col salvacar; cuidad juarez 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14349620
• Report Number: 2210968-2022-03564
• Device Sequence Number: 4856963
• Product Code: GAM
• UDI-Device Identifier: 10705031040151
• UDI-Public: 10705031040151
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: J464G
• Device Catalogue Number: J464G
• Device Lot Number: RCMAMU
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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