MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	M8710
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: representative samples were received for evaluation.Six boxes with twelve unopened samples each of product code (b)(4), lot mmj097 were returned for analysis.As total was received sixty unopened samples.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.Per the conditions of the sample received, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.A manufacturing record evaluation was performed for the finished device lot number mmj097 and no non-conformance's were identified.
Event or Problem Description
It was reported that the patient underwent a cardiovascular procedure on (b)(6) 2019 and suture was used.The needle separated from the suture during use.Another like device was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: PROLENE SUTURE 30"(75CM) 5-0 BLU
• 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: 8537054
• Report Number: 2210968-2019-80576
• Device Sequence Number: 18925773
• Product Code: GAW
• UDI-Device Identifier: 10705031045842
• UDI-Public: 10705031045842
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 03/28/2019

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: 10/31/2023
• Device Catalogue Number: M8710
• Device Lot Number: MMJ097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1