MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 4-0 S/A SH-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J771D
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The surgeon felt that the suture had been thicker than usual after the package was opened.There were no adverse consequences to the patient.

• Brand Name: VCL CT BRD VIO 8X18IN 4-0 S/A SH-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: 8809868
• Report Number: 2210968-2019-84499
• Device Sequence Number: 10842872
• Product Code: GAM
• UDI-Device Identifier: 10705031042858
• UDI-Public: 10705031042858
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/25/2019

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: 12/31/2023
• Device Catalogue Number: J771D
• Device Lot Number: PA5277
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/20/2019
• Patient Sequence Number: 1