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

Catalog Number	VCP751D
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/14/2024.H6 component code: g07002 - device not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but unavailable: where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?) please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? what was the texture? are there any photos of the foreign matter available? is it possible that the foreign material fell into packaging upon opening of device? was the product seal on the foil still intact when the package was opened? was the procedure completed without any adverse effect to the patient? please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).Contacted with the sales rep today via phone, please refer to the event description and other information requested is unknown.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.
Event or Problem Description
It was reported a patient underwent a c-section procedure on (b)(6) 2024 and suture was used.A transverse incision was made in the lower segment of the uterus during surgery.During the surgical process, the doctor need to use suture to suture the patient's wound.When opening a new and complete package of sutures, an unknown residue was found on the needle.The nurse and doctor immediately replaced it with another package of suture.After replacement, no abnormalities were found, and the surgery proceeded smoothly.There was no patient consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 8X18IN 2-0 S/A CT CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19982563
• Report Number: 2210968-2024-08503
• Device Sequence Number: 2736783
• Product Code: GAM
• UDI-Device Identifier: 10705031055292
• UDI-Public: (01)10705031055292(11)231101(17)281031(10)TMMALP
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: VCP751D
• Device Lot Number: TMMALP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: 24 YR
• Patient Sex: Female