MAUDE Adverse Event Report: ETHICON INC. VCL CT UD 36IN 0 S/A CTXB; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	JB978
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 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 the patient underwent an unknown procedure on unknown date and suture was used.The suture popped off the needle.Needle pulled off the suture and was retrieved from the patient.Another device was used to complete the procedure.There was no adverse consequence to the patient reported.

• Brand Name: VCL CT UD 36IN 0 S/A CTXB
• 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: 8620711
• Report Number: 2210968-2019-81484
• Device Sequence Number: 11305961
• Product Code: GAM
• UDI-Device Identifier: 10705031044104
• UDI-Public: 10705031044104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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 Catalogue Number: JB978
• Device Lot Number: MD5183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/17/2019
• Patient Sequence Number: 1