MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8IN 8-0 D/A TG140-8; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J547G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pbk713 batch number, and no non-conformance's were identified.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.Confirm the specific number of devices (total qty actually involved with reported issue) that failed during this one reported event same patient/ single procedure or over multiple procedures? if all 3 reported devices failed during use on same patient/ single procedure, confirm when event noticed/occurred- pre-op-before use on patient? or intra-op- during use on patient while suturing? if multiple procedures, please confirm the specific number of patient events /procedures?, have any of these events been previously reported to ethicon? if yes, please provide complaint file number/ affiliate number, for each patient event please provide additional complaint details: event date, product code and lot number involved, procedure, event description, qty involved? was there any adverse patient outcome? if yes, was there any medical or surgical intervention performed, was procedure completed successfully and how? any sample return.Etc? note: events reported via mw # 2210968-2019-88105, 2210968-2019-88106.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient.

• Brand Name: VCL CT BRD VIO 8IN 8-0 D/A TG140-8
• 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: 9119106
• Report Number: 2210968-2019-88107
• Device Sequence Number: 11453800
• Product Code: GAM
• UDI-Device Identifier: 10705031041110
• UDI-Public: 10705031041110
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: J547G
• Device Lot Number: PBK713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/25/2019
• Patient Sequence Number: 1