MAUDE Adverse Event Report: ETHICON INC. VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J839D
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: please clarify, what do you mean by " soiled inside the foil pack "? was there any foreign matter found on the inside of the suture pack? or was there any stain / ink smudge on the inside of the package? the soil was found on the inside of the foil pack.Was the sterility of suture product compromised in any way? (package not sealed/any hole or tear or puncture in package) causing the issue reported in event? the sterility of the product was compromised.A pic of the product is attached.
Event or Problem Description
It was reported that a patient underwent a cabg on (b)(6) 2018, and suture was used.When the box of suture was opened, it appeared that one of the control release packages was soiled inside the foil pack and that the sterility of the product was compromised.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/28/2018.Evaluation: initially a picture of the sample was received for analysis.Upon visual inspection of the picture, a stain in a control release sample of product could be observed.However, no conclusion could be reached as to the origin of the foreign matter.An empty opened box , an empty opened foil, a paper lid, a winding former with eight needle-suture combinations and twelve unopened samples of product were returned for analysis.During the visual inspection of the paper lid, a brown stain was noted.The winding former was examined and a brown stain were observed on the back of the tray, the suture were dispensed without problems and no foreign matter were noted on the strands.In the inspection of the foil the integrity of package was not compromised.During the visual inspection of twelve unopened samples, no defects were found on the packages.The samples were opened, and no foreign matter was observed; nor the integrity of packages were compromised.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the opened sample, foreign matter was found, but the reported complaint per packaging integrity could not be confirmed due to the integrity of package observed not being compromised.Per the condition of twelve unopened samples, no packaging foreign matter non-biological or packaging integrity were found.

• Brand Name: VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR
• 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: 8111672
• Report Number: 2210968-2018-77376
• Device Sequence Number: 16577571
• Product Code: GAM
• UDI-Device Identifier: 10705031043220
• UDI-Public: 10705031043220
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: 07/31/2023
• Device Catalogue Number: J839D
• Device Lot Number: MJ2985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 12/28/2018
• Patient Sequence Number: 1