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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
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.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.This medwatch report is in response to receipt of maude event report #mw5080600.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and suture was used.During the procedure, the suture was opened, however the item inside was labeled as different product code.There were no adverse patient consequences reported.No additional information was provided.

• 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: 8124678
• Report Number: 2210968-2018-77446
• Device Sequence Number: 1653139
• Product Code: GAM
• UDI-Device Identifier: 10705031043220
• UDI-Public: 10705031043220
• Combination Product (Y/N): N
• 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,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

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: 05/31/2023
• Device Catalogue Number: J839D
• Device Lot Number: MG2349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 12/03/2018
• Patient Sequence Number: 1