MAUDE Adverse Event Report: ETHICON INC. VCL CT SUT 1X54IN(135CM) 0 VIO; 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	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mk6373 number, and no non-conformances were identified.Additional information was requested and the following was obtained: was the information on the label on the outer box and that on the individual foils different with respect to suture size, 0 and 2-0? the information on the foil and the outer box are the exact same.What was the product code and lot number on the outer box and that the foil? same on both.What was the actual size of the suture in the foil labeled as 2-0 appear to be, 0 or 2-0? 2-0.Was the issue found upon opening a new box of product? no.Is it possible that 2 products got mixed up on the shelf? no foil and box had same info.The indication on the product reel itself inside the foil indicated it was a 2-0 not 0.Was it verified that all the packages/foils in the box were same and labeled as 2.0? no.An empty opened box and an opened sample of product code j207, lot mk6373 was returned 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.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, the assignable cause of the mix reel is due a manufacturing defect.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The nurse opened the tie reel and realized the reel stated this was a 2-0 reel of ties (two dots) and not a 0 as the product code and box indicates.No adverse patient consequences.Additional information was requested.

• 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: 8631893
• Report Number: 2210968-2019-81664
• Device Sequence Number: 13863948
• Product Code: GAM
• UDI-Device Identifier: 10705031038158
• UDI-Public: 10705031038158
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 04/25/2019

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: 04/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/22/2019
• Patient Sequence Number: 1