MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 7-0 D/A BV-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EP8703H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: was there any adverse patient outcome? no.Device return status? on the way.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Events reported via 2210968-2022-06912, 2210968-2022-06913, 2210968-2022-06914, and 2210968-2022-06915.
Event or Problem Description
It was reported that a patient underwent an unknown procedure and the suture was used.During surgery, the suture was torn during bypass procedure (vessel wall), after 1st - 2nd knot (1-2 tissue passages).In relation to the needle, the suture tore approximately in the middle.The suture was exchanged against same like product.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/6/2022 h6 component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that it was received one open box with twenty-five unopened samples pertain to the product code ep8703h.As per the sampling plan, a visual inspection was performed on thirteen samples, no defects were found on the packages.The packets 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 strand and no issue related to breakage suture or anomalies were observed during evaluation.Also, a functional test was performed using an instron equipment and the pull force and tensile force were above the minimum requirements.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Related reports: 2210968-2022-06912, 2210968-2022-06913, 2210968-2022-06914, and 2210968-2022-06915.

• Brand Name: PRLNE BLU 30IN 7-0 D/A BV-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15292972
• Report Number: 2210968-2022-06911
• Device Sequence Number: 7139112
• Product Code: GAW
• UDI-Device Identifier: 10705031206830
• UDI-Public: 10705031206830
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 04/30/2024
• Device Catalogue Number: EP8703H
• Device Lot Number: PEJ413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown