MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 0 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP370H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device qgbdbzx0 number, and no non-conformances related to the reported complaint condition were identified.Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent a c-section on (b)(6) 2021 and the suture was used.It was reported that during the knot tying of the stitch in the apex of the wound where it broke on the first knot multiple times.The suture broke while tying the knot.Another thicker suture was used to complete the procedure successfully.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/15/2021.This report was initially sent on 3/1/2021 and was stuck in ack2.Resubmitted 3/15/2021.Reference: (b)(4).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 h3 investigation summary: the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that twenty-six samples of product code vcp370 were received for evaluation.Visual inspection of thirteen unopened samples and no defects were found on the package.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects, damage or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The device performed without any defect noted.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Trade name - irgacare®; active ingredient(s) ¿ triclosan; dosage form ¿ suture/solid/parenteral; strength ¿ = 275 g/m.

• Brand Name: VCL+ VIO 36IN 0 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11228078
• Report Number: 2210968-2021-00680
• Device Sequence Number: 4018164
• Product Code: GAM
• UDI-Device Identifier: 10705031052833
• UDI-Public: 10705031052833
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: 05/31/2023
• Device Model Number: VCP370H
• Device Catalogue Number: VCP370H
• Device Lot Number: QGBDBZX0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/15/2021
• Patient Sequence Number: 1