MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J397H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was rep at (b)(6) for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot pa2496, and no non-conformances were identified.To date the device has not been returned.
Event or Problem Description
It was reported that a patient underwent a cesarean section procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture pulled off the needle when sewing.Changed another one to complete the surgery.There were no adverse patient consequences reported.No additional information could be provided.

• Brand Name: VCL CT BRD VIO 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10178846
• Report Number: 2210968-2020-04678
• Device Sequence Number: 11340206
• Product Code: GAM
• UDI-Device Identifier: 10705031039575
• UDI-Public: 10705031039575
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: 12/31/2023
• Device Model Number: J397H
• Device Catalogue Number: J397H
• Device Lot Number: PA2496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/22/2020
• Patient Sequence Number: 1
• Patient Age: 23 YR