MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 18"(45CM) 5-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y493G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.When did the needle pull off (while in the package / during dispensing / during preparation / during use)?.
Event or Problem Description
It was reported that a patient underwent a skin excision procedure on an unknown date and suture was used.During the procedure, the needle came away from the suture.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: MONOCRYL SUTURE 18"(45CM) 5-0 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: 7700128
• Report Number: 2210968-2018-74497
• Device Sequence Number: 11125941
• Product Code: GAN
• UDI-Device Identifier: 10705031059313
• UDI-Public: 10705031059313
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2018

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: 10/31/2021
• Device Catalogue Number: Y493G
• Device Lot Number: KM6728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/18/2018
• Patient Sequence Number: 1