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

Model Number	J333H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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 that a patient underwent an unknown urological procedure on (b)(6) 2019 and suture was used.When opening the package, it was found that there had been a double-armed suture though it should be single-armed.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/4/2020.A manufacturing record evaluation was performed for the finished device pb2169, and no non-conformances were identified.H3 investigation summary: it was reported that the device had assembly product mix / incorrect component.It was received for analysis an opened sample of product code j333h, lot pb2169.This product code is single armed.During the visual inspection of the sample, it was observed an extra needle/suture into the winding former; resulting in a wrong number of components in the package, this is different than the requirements for the product j333 of a strand single armed per package.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of the product mix / incorrect component is an extra-needle/suture.

• Brand Name: VCL CT BRD VIO 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9571802
• Report Number: 2210968-2020-00227
• Device Sequence Number: 18942235
• Product Code: GAM
• UDI-Device Identifier: 10705031038912
• UDI-Public: 10705031038912
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 12/13/2019

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: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: J333H
• Device Catalogue Number: J333H
• Device Lot Number: PB2169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/04/2020
• Patient Sequence Number: 1