MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 4-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J310H
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).Attempts are being 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 enterectomy on an unknown date and suture was used.The needle was pulling from the suture after the 1st stitch, it was found that the suture had broken in the middle of it.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).It was reported that the device had performance breakage suture.It was received for analysis a needle suture piece and a suture piece of product code j310h.During the visual inspection of needle/suture piece, marks on the body needle that appears to be by use of surgical instruments was noted; also, the sutures pieces present body fluids and was damaged(busted).Functional test could not be performed due to condition of the samples.The manufacturing records couldn¿t be reviewed as the batch number is unknown.According to the sample condition, the assignable cause of the performance breakage suture, was suggest an improper handling.

• Brand Name: VCL CT BRD VIO 27IN 4-0 S/A SH-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: 9079274
• Report Number: 2210968-2019-87673
• Device Sequence Number: 2451469
• Product Code: GAM
• UDI-Device Identifier: 10705031038677
• UDI-Public: 10705031038677
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 08/23/2019

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: J310H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/28/2019
• Patient Sequence Number: 1