MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN 0 S/A CTB-1 CR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number PDPB740D

Device Problems Break (1069); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The following information was requested, but unavailable: were there any unexpected outcomes or complications as a result of the prolonged surgery time? no further information is available.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain no further information is available.Please provide the procedure name and date.No further information is available.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.Events reported via: (b)(4).

Event Description

It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the surgery, the suture broke.The suture breakage occurred with 6 sutures in total, so insufficient strength of the suture was suspected, and use was stopped.The wound closure was completed using another package.The operation time was extended within 30 minutes.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 5/19/2021.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, 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 h3 investigation summary: the product was returned to ethicon inc for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one winding former with two-needle/sutures combination, a dispensed suture, and a top foil product code pdpb740d were received for evaluation, the swage, and attachment area of the needles were noted to be as expected.The sutures have begun with the degradation and the functional test could not be confirmed due to this condition.The product code pdpb740d contains absorbable suture and as the sample was received open, the time of exposure of suture to the environment could not be determined.The top foil was inspected and two holes in the cavity and excessive wrinkles were noted.This condition contributed to the degradation of the suture.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.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ¿g/m.

• Brand Name: PDS PLUS VIO 8X18IN 0 S/A CTB-1 CR
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11611524
• MDR Text Key: 243843320
• Report Number: 2210968-2021-03006
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031218840
• UDI-Public: 10705031218840
• Combination Product (y/n): Y
• PMA/PMN Number: K061037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: PDPB740D
• Device Lot Number: RAMMAU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1