MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 3-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J338H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts to obtain the following information have been made with no response to date.If further details are received at a later date a supplemental medwatch will be sent.Were total 5 devices, j370h (1), j340h (2)and j338h(2) used in this procedure? did all devices have needle pull off issue during actual use on patient? how was case completed? are any samples available for evaluation? lot numbers device return status? related needle pull of device issues captured in reports: 2210968-2019-90736, 2210968-2019-90738, 2210968-2019-90739, 2210968-2019-90740 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 a patient underwent a cardiovascular procedure on an unknown date in 2019 and suture was used.The needle popped off suture.It was not reported how the procedure was completed.The actual suture was discarded.This is all the information known/available.There were no patient consequences reported.

• Brand Name: VCL CT BRD VIO 27IN 3-0 S/A CT-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: 9448717
• Report Number: 2210968-2019-90737
• Device Sequence Number: 16705026
• Product Code: GAM
• UDI-Device Identifier: 10705031038998
• UDI-Public: 10705031038998
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

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: J338H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/10/2019
• Patient Sequence Number: 1