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

Model Number	VCPB340H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a c-section procedure on (b)(6) 2022 and suture was used.During the procedure, it was reported that the problem of pulling off suture needle happened when sewing the uterus during the surgery.Another like device was used to complete the surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 tissue/location was suturing when pull off occurred? were there any unexpected outcomes or complications as a result of this suture needle pull off event? was the needle piece removed from the patient during the same procedure? was there any patient consequence or injury? what medical/surgical intervention was provided? what is the condition of the patient? trade name: irgacare®, active ingredient(s): triclosan, dosage form: suture/solid/parenteral, strength: = 275 g/m.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 4/7/2022 h6 component code: g07002 device not returned 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: d4, h4, h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, but unavailable: what tissue/location was suturing when pull off occurred? were there any unexpected outcomes or complications as a result of this suture needle pull off event? was the needle piece removed from the patient during the same procedure? was there any patient consequence or injury? what medical/surgical intervention was provided? what is the condition of the patient? ¿¿ all answers above are unobtainable.Once there is any update, we will update the information.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 275 ¿g/m.

• Brand Name: VCL+ VIO 27IN 0 S/A CTB-1
• 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; cuidad juarez PR ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13715164
• Report Number: 2210968-2022-01624
• Device Sequence Number: 15046334
• Product Code: GAM
• UDI-Device Identifier: 10705031056398
• UDI-Public: 10705031056398
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 10/31/2025
• Device Model Number: VCPB340H
• Device Catalogue Number: VCPB340H
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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 Age: 28 YR
• Patient Sex: Female