MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 3-0 S/A CTB-2 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	D10158
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).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 lot, and no non-conformances were identified.The following information was requested, but was unavailable: event date? =>no further information is available.Procedure name and date? =>no further information is available.No further information will be provided.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.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength -= 275 ¿g /m.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the product fell when the package was opened, probably because the sealing was loose.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).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 lot, and no non-conformances were identified.The following information was requested, but was unavailable: event date? =>no further information is available.Procedure name and date? =>no further information is available.No further information will be provided.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.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength -= 275 ¿g /m.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the product fell when the package was opened, probably because the sealing was loose.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 8X18IN 3-0 S/A CTB-2 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: 13579687
• Report Number: 2210968-2022-01233
• Device Sequence Number: 17524504
• Product Code: GAM
• UDI-Device Identifier: 10705031231009
• UDI-Public: 10705031231009
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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: 07/31/2026
• Device Model Number: D10158
• Device Catalogue Number: D10158
• Device Lot Number: RJMJCS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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