MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV-1 VB; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	M8304
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a coronary artery bypass graph on (b)(6) 2019 and the suture was used.During the procedure, the suture kept popping off the needle at the swage.Another like suture was used to complete the procedure.There are no patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 09/20/2019.A manufacturing record evaluation was performed for the finished device number, and no non-conformances were identified.H3 device evaluation summary: it was received one sealed box with twelve unopened samples and one opened box with eight unopened samples of product code m8304, lot pbj959.The complaint sample was not received for analysis.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 performance pull off suture needle was found, and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 2 device issues captured in report 2210968-2019-85968.Analysis results have been included in follow up reports for each.

• Brand Name: PRLNE BLU 4X24IN 7-0 D/A BV-1 VB
• 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: 8919199
• Report Number: 2210968-2019-85966
• Device Sequence Number: 290998
• Product Code: GAW
• UDI-Device Identifier: 10705031045644
• UDI-Public: 10705031045644
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• 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,Followup
• Report Date (Section B): 07/26/2019

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: 01/31/2024
• Device Catalogue Number: M8304
• Device Lot Number: PBJ959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/20/2019
• Patient Sequence Number: 1