MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 8-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8730H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts have been made to obtain 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.
Event or Problem Description
It was reported a patient underwent a coronary artery bypass graft on (b)(6) 2019 and suture was used.The needle was detached from the suture easily during anastomosis by continuous suturing.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).It was received for analysis an unopened sample of product code 8730, lot lmh034.The complaint sample was not received.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, or damage 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 conditions of the sample received, no pull off suture needle was found, and the tested sample met the finished goods requirements.
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PROLENE SUTURE 18"(45CM) 8-0 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: 8593255
• Report Number: 2210968-2019-81136
• Device Sequence Number: 13971810
• Product Code: GAW
• UDI-Device Identifier: 10705031019874
• UDI-Public: 10705031019874
• 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,Followup
• Report Date (Section B): 04/11/2019

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: 10/31/2022
• Device Catalogue Number: 8730H
• Device Lot Number: LMH034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019; 06/03/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/31/2019; 06/25/2019
• Patient Sequence Number: 1