MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 54IN 0 NON NDL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J207G
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	05/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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 manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that the device appears to be "0" vicryl ties but placed onto the "2/0" reel.Packaged in "0 vicryl" packaging.This has been noticed frequently recently.No patient involvement reported.
Additional Manufacturer Narrative
The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.Additional h-3 summary: it was received one opened sample of product code j207, lot mk6373 for analysis.During the visual inspection of the opened sample, the spool had two holes punched and for product code j207 should be only one hole punched.Due to mismatch at the spool a characterization of the suture was performed and meet the requirements for a vicryl suture diameter 0.According to the sample condition, the assignable cause of the mix reel is due a manufacturing defect.The single complaint was reported with multiple events.There are no additional details regarding the additional events.

• Brand Name: VCL CT BRD VIO 54IN 0 NON NDL
• 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: 8698490
• Report Number: 2210968-2019-82738
• Device Sequence Number: 19316695
• Product Code: GAM
• UDI-Device Identifier: 10705031038158
• UDI-Public: 10705031038158
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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: 08/31/2023
• Device Catalogue Number: J207G
• Device Lot Number: MK6373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1