MAUDE Adverse Event Report: ETHICON INC. VCL CT SUT 1X54IN(135CM) 0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J207G
Medical Device Problem Codes	Component Incompatible (1108); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.
Event or Problem Description
It was reported that the internal packaging of suture does not match the box packaging or packaging of suture.There is size 0 on the box, size 0 on the suture packaging, but suture is 2-0.The procedure was completed successfully.No adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional evaluation summary: an opened box and an unopened sample of product code j207, lot mk6373 were returned for analysis.During the visual inspection of the unopened sample, no defects were found on the package.The sample was opened and 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 to a manufacturing defect.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: VCL CT SUT 1X54IN(135CM) 0 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: 8524482
• Report Number: 2210968-2019-80469
• Device Sequence Number: 2869157
• 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: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 08/31/2023
• Device Catalogue Number: J207G
• Device Lot Number: MK6373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/07/2019
• Patient Sequence Number: 1