MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 4-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J214H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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.
Event or Problem Description
It was reported that a patient underwent a breast lumpectomy on (b)(6) 2019 and suture was used.During the procedure, the suture frayed easily.The procedure was completed with a alternate like device with no adverse patient consequences reported.There is no additional information.

• Brand Name: VCL CT BRD UD 27IN 4-0 S/A RB-1
• 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: 8748297
• Report Number: 2210968-2019-83480
• Device Sequence Number: 11184925
• Product Code: GAM
• UDI-Device Identifier: 10705031038226
• UDI-Public: 10705031038226
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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: J214H
• Device Lot Number: MJK740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/01/2019
• Patient Sequence Number: 1