MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 3X18IN 2 S/A CTXB CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	D10045
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
(b)(4).Attempts have been made to retrieve the device.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 an unknown procedure on unknown date in 2019 and suture was used.The suture had been detached from the needle.It was a control release needle.Further details are not available.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Additional summary: one empty opened folder, a detached needle and one dispensed suture were returned for analysis.The product code is control release and required three strands per packet.During the visual inspection of the needle the swage and attachment area were as expected.The barrel hole of the needle was examined and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.The manufacturing records could not be reviewed as the batch number is unknown.Per the sample condition, the assignable cause of the performance - pull off - suture needle is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.

• Brand Name: VCL+ VIO 3X18IN 2 S/A CTXB 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: 8805160
• Report Number: 2210968-2019-84467
• Device Sequence Number: 342770
• Product Code: GAM
• UDI-Device Identifier: 10705031134300
• UDI-Public: 10705031134300
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K810428
• 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,Followup
• Report Date (Section B): 06/24/2019

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 Catalogue Number: D10045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/22/2019
• Patient Sequence Number: 1