MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 36"(90CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP519H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Event or Problem Description
It was reported that a patient underwent an unknown procedure and suture was used.During the closure the suture broke.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: an opened box with thirty-two unopened samples of product code vcp519, lot mmbbqbs0 were returned for analysis.During the visual inspection of thirteen samples, no defects were found on the packages.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 of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Representative samples returned to support investigation of 3 device issues captured in reports 2210968-2019-79753, 2210968-2019-79754 and 2210968-2019-79755.Analysis results have been included in follow-up reports for each.

• Brand Name: VICRYL PLUS SUTURE 36"(90CM) 1 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8458737
• Report Number: 2210968-2019-79754
• Device Sequence Number: 18918614
• Product Code: GAM
• UDI-Device Identifier: 10705031054066
• UDI-Public: 10705031054066
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 03/04/2019

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: No Information
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: VCP519H
• Device Lot Number: MMBBQBS0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/03/2019
• Patient Sequence Number: 1