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

Catalog Number	J207G
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/28/2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 procedure on (b)(6) 2019 and suture was used.During the procedure, it was noted that a 2-0 reel was in 0 packaging.Two circle cutout on reel indicating it's a 2-0.The reporter was unsure the actual suture present on the reel.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).It was reported that the device had an assembly product mix / incorrect component issue.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.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.It was received two unopened samples of product code j207, lot mk6373 for analysis.During the visual inspection of the unopened samples, 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.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.Representative samples returned to support investigation of 4 device issues captured in reports 2210968-2019-84459, 2210968-2019-84460, 2210968-2019-84461, and 2210968-2019-82071.Analysis results have been included in reports for each.

• 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: 8648340
• Report Number: 2210968-2019-82071
• Device Sequence Number: 1936045
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 05/03/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1