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

Catalog Number	M8710
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
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 a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a cardiac 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.No devices will be returned.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: representative samples were received for evaluation.Six boxes with twelve unopened samples each of product code m8710, 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 review was performed for the finished device batch mmj097 and no non-conformances were identified.Representative samples returned to support investigation of 2 device issues captured in reports 2210968-2019-80576 and 2210968-2019-80676.Analysis results have been included in follow-up reports for each.

• 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: 8544927
• Report Number: 2210968-2019-80676
• Device Sequence Number: 13885964
• 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,Followup
• 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?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/31/2019
• Patient Sequence Number: 1