MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP340H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device rd2aha and no non conformances / manufacturing irregularities related to the malfunction were identified (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.What was the size of the needle used? was there any additional tissue damage as a result of searching for the needle piece? what is current condition of the patient? is there any photo available to visual analysis? trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 g/m.
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2021 and suture was used.During the procedure, when suturing, the needle snapped in half.The fragment was retrieved and a new suture was used to complete the case with no adverse patient consequences.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 9/28/2021.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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: what was the size of the needle used? ct-1 needle.Was there any additional tissue damage as a result of searching for the needle piece? no additional damage is there any photo available to visual analysis? no photo.¿ trade name - irgacare®.¿ active ingredient(s) ¿ triclosan.¿ dosage form ¿ suture/solid/parenteral.¿ strength ¿ = 275 g/m.

• Brand Name: VCL+ VIO 27IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12385885
• Report Number: 2210968-2021-07791
• Device Sequence Number: 20008413
• Product Code: GAM
• UDI-Device Identifier: 10705031052499
• UDI-Public: 10705031052499
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 03/31/2026
• Device Model Number: VCP340H
• Device Catalogue Number: VCP340H
• Device Lot Number: RD2AHA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/28/2021
• Patient Sequence Number: 1