MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 1 S/A CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP268H
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
Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the specific number of devices (total qty involved) that failed during this one procedure? is actual product or unopened samples available to be returned for investigation?.
Event or Problem Description
It was reported that a patient underwent an unknown surgical procedure on an unknown date and suture was used.The needle popped off of the suture during use.No adverse patient consequences were reported.

• Brand Name: VCL+ UD 27IN 1 S/A CP-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: 8867787
• Report Number: 2210968-2019-85225
• Device Sequence Number: 11396464
• Product Code: GAM
• UDI-Device Identifier: 10705031051898
• UDI-Public: 10705031051898
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

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: 01/31/2024
• Device Catalogue Number: VCP268H
• Device Lot Number: PB2174
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/06/2019
• Patient Sequence Number: 1