MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 8-0 D/A BV175-6 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EP8740H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.
Event or Problem Description
It was reported that the patient underwent an open coronary artery bypass graft procedure on (b)(6) 2019 and suture was used.The needle was detached from the suture during vascular anastomosis for the lit-lad by continuous suture.Another like device was used to complete the procedure.The procedure time was extended within 30 minutes.There were no patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Additional investigation summary: one empty opened box and fourteen unopened samples of product code ep8740, lot mkr840 were returned for analysis.The product code is double armed.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no pull off suture needle was found, and the tested samples met the finished goods requirements.An empty opened folder, one detached needle and needle-suture of product code ep8740, lot mkr840 were returned for analysis.The product code is double armed.During the visual inspection of the detached needle, the swage and attachment area were noted to be as expected, but slightly marks appears to be by use of surgical instrument could be found on the body needle.Also, the needle-suture was examined, the swage and attachment area were noted to be as expected; however, the end suture was flat and cut.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition,the assignable cause of pull off suture needle, suggest an improper handling of the sample.

• Brand Name: PRLNE BLU 18IN 8-0 D/A BV175-6 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8708597
• Report Number: 2210968-2019-82863
• Device Sequence Number: 2072907
• Product Code: GAW
• UDI-Device Identifier: 10705031206694
• UDI-Public: 10705031206694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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): 05/24/2019

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: 08/31/2023
• Device Catalogue Number: EP8740H
• Device Lot Number: MKR840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 08/09/2019
• Patient Sequence Number: 1