MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X30IN 6-0 D/A CC-1 MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	M8707
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.Summary: one empty opened overwrap and one opened straight pack with two needle-suture combinations of product were returned for analysis.The product code m8707 is multi-strand and required four strands double armed per packet.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The sutures were dispensed and no defects or damaged were noted.Functional test was performed on the sample and the pull force did not meet the minimum ltl.According to the sample condition the assignable cause is pull out defect due to light swage.Three unopened samples were returned for evaluation.The product code m8707 is multi-strand and required four strands double armed per packet.During the visual inspection of samples, no defects were found on the packages.The samples were opened, and contains four strands double armed each.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 condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that the patient underwent a coronary artery bypass graft procedure on (b)(6) 2019 and the suture was used.During the procedure, the suture came off the needle.Another like suture was used to complete the procedure.There were no patient consequences reported.

• Brand Name: PRLNE BLU 4X30IN 6-0 D/A CC-1 MP
• 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: 8971937
• Report Number: 2210968-2019-86662
• Device Sequence Number: 2459154
• Product Code: GAW
• UDI-Device Identifier: 10705031045828
• UDI-Public: 10705031045828
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2019

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: M8707
• Device Lot Number: MKH713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/06/2019
• Patient Sequence Number: 1