MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP363H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Summary: it was received for analysis an opened box with twenty-one unopened samples of product.The complaint sample was not received.During the visual inspection of unopened samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed the pull force were above the minimum requirements.Per the condition of the samples received, no pull off suture needle was found, and the tested samples met the finished goods requirements.Second suture event was submitted via medwatch 2210968-2020-02107.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2020 and the suture was used.It was reported that during the procedure, the needle came out from the suture; the suture pulled off occurred.

• Brand Name: VCL+ VIO 27IN 2-0 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: 9833902
• Report Number: 2210968-2020-02108
• Device Sequence Number: 14220242
• Product Code: GAM
• UDI-Device Identifier: 10705031052758
• UDI-Public: 10705031052758
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 09/30/2022
• Device Model Number: VCP363H
• Device Catalogue Number: VCP363H
• Device Lot Number: PLBGJBS0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/16/2020
• Patient Sequence Number: 1