MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X18IN 0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP840D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).H3 device analysis: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.The returned sample determined that it was received one winding former with five undispensed strands along with an empty opened foil that pertain to the product code vcp840d.In order to evaluate the condition of the returned sample, no pull off was noted.The suture was dispensed without problems and examined along the strand and no issues or anomalies were observed during the evaluation.The product code vcp840d contains an absorbable suture and the time of exposure of suture in the environment could not be determined.The functional test could not be performed.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.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.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.1.Please clarify how the procedure was complete a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 275 g/m.Events reported via: 2210968-2023-05661.
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 sales rep reported that the needle kept popping off suture without pressure.New suture was used to complete procedure.There was no delay.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ UD 8X18IN 0 S/A CT-1 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 ; 9083863534
• MDR Report Key: 17477290
• Report Number: 2210968-2023-05662
• Device Sequence Number: 2773367
• Product Code: GAM
• UDI-Device Identifier: 10705031055773
• UDI-Public: 10705031055773
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2023

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: VCP840D
• Device Lot Number: TBMLCQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown