MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18"(45CM) 6-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	D5264
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2018
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.
Event or Problem Description
It was reported that customer ordered the suture product with the understanding that it would come with a certain size and type of needle (s24).The box that they received displays it has a different, labeled needle (s14).The sutures inside also display s14.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 09/18/2018 evaluation: a sealed box, an unopened box with an empty opened foil, and unopened samples of product were returned for analysis.During the visual inspection of the samples, the information of product code, lot number and graphic on the label overwrap and paper lid printed was compared with system database.In addition, a characterization was performed.The characterization of the sample was conducted, and the following was observed: the sample was measured in needle diameter, point type, needle type, needle radius/curvature and angle belong to product code d5264.Also, the suture was measured in diameter suture and length and the structure of the strand belong to vicryl suture diameter 6-0¿and it is correct to the product code d5264.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.However, when the code was reviewed on the ethicon web product catalog, it was found to have a different product on the photo and the characteristics don¿t correspond to the physical samples received.The product show at the web page belongs to a different product.Per the condition of the sample received and the information of the customer, the difference on the homepage corresponds to the reported complaint.However, the samples received meet the finish good requirements.

• Brand Name: VICRYL SUTURE 18"(45CM) 6-0 UND
• 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: 7736005
• Report Number: 2210968-2018-74771
• Device Sequence Number: 10950663
• Product Code: GAM
• UDI-Device Identifier: 10705031025356
• UDI-Public: 10705031025356
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: 09/30/2022
• Device Catalogue Number: D5264
• Device Lot Number: LLK499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 09/18/2018
• Patient Sequence Number: 1