MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 0 S/A CTX; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8454H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Note: events reported in 2210968-2020-06722, 2210968-2020-06721, 2210968-2020-06725, 2210968-2020-06723.Attempts have been made to retrieve 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.Additional information was requested and the following was obtained: could you please provide product code? please confirm device's availability.The code number 8454h as in the picture attached.The doctor used another suture brand to complete the closure.No complications happened to the patient as the surgeon changed the suture.The patient is in good status.Yes, all the five sutures available for return.Lot: mmh358.
Event or Problem Description
It was reported that a patient underwent a laparoscopic procedure on (b)(6) 2020 and suture was used.During the procedure, the suture pulled off the needle.The event reoccurred 5 times with 5 sutures from the same batch during the same case.Another like device was used to complete the procedure.There were no adverse events or patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 12/17/2020.Additional h6 component code: g07002 ¿ conforming device.Additional h3 investigation summary: an empty labeled winding former and a needle/suture piece of product code 8454, lot # mmh358 were received for evaluation.During the visual inspection of the needle/suture piece, the swage and attachment area were noted to be as expected and marks by use of a surgical instrument could be observed.During the visual of the suture piece, it was noted stress and damage on the surface suture (fraying and slice/split), that appears to be by use of surgical.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The condition of the sample received suggest an improper handling.Additional h3 investigation summary: a sealed sample of product code 8454, lot # mmh358 was received for evaluation.During the visual inspection of the unopened sample, no defects were found on the package.The sample was opened, and 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, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The device performed without any defect noted.Note: events reported via mw# 2210968-2020-06723, 2210968-2020-06722, 2210968-2020-06721, 2210968-2020-06725.This report is being submitted pursuant to the provisions of 21 cfr, parts 4 and 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.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 11/24/2020.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device batch mmh358, 8454h19 and no non-conformances were identified.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.

• Brand Name: PRLNE BLU 30IN 0 S/A CTX
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10505859
• Report Number: 2210968-2020-06724
• Device Sequence Number: 16448494
• Product Code: GAW
• UDI-Device Identifier: 10705031015845
• UDI-Public: 10705031015845
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2020

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 Model Number: 8454H
• Device Catalogue Number: 8454H
• Device Lot Number: MMH358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 11/18/2020; 12/15/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 11/24/2020; 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1