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

Model Number	J451H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device me5176 batch number, and no non-conformance's were identified.To date, the device has not been returned.If the device or further details are received, a supplemental medwatch will be received.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a cesarean section procedure on (b)(6) 2020 and suture was used.During the procedure, when sewing the skin during the cesarean section, the suture pulled off the needle.Another like device was used to complete the procedure.There were no adverse events or patient consequences reported.No additional information could be provided.

• Brand Name: VCL CT BRD VIO 27IN 4-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10513456
• Report Number: 2210968-2020-06759
• Device Sequence Number: 3202898
• Product Code: GAM
• UDI-Device Identifier: 10705031039995
• UDI-Public: 10705031039995
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2020

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: 04/30/2023
• Device Model Number: J451H
• Device Catalogue Number: J451H
• Device Lot Number: ME5176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/10/2020
• Patient Sequence Number: 1