MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 36"(90CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP956H
Medical Device Problem Code	Component Incompatible (1108)
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).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 a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the suture was opened and passed off to the field and the actual suture that was inside the package was not the same.The foil wrap said one product code and the actual suture was different.Another like device with the correct product code was used to complete the procedure with no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: the actual device batch number associated with this event is not known.The possible batch numbers are reported as follows: batch mj7031 mfg date: 08/18/2018, exp date: 07/31/2023.Batch kbk720 mfg date: 02/25//2016, exp date: 01/31/2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being 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.

• Brand Name: VICRYL PLUS SUTURE 36"(90CM) 3-0 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: 8492118
• Report Number: 2210968-2019-80098
• Device Sequence Number: 13933612
• Product Code: GAM
• UDI-Device Identifier: 10705031056183
• UDI-Public: 10705031056183
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• 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): 03/12/2019

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: 07/31/2023
• Device Catalogue Number: VCP956H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/11/2019
• Patient Sequence Number: 1