MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 27IN USP0; SUTURE, SURGICAL, ABSORBABLE

Catalog Number PDP2017H

Device Problem Insufficient Information (3190)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(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.The following information was requested, but unavailable: 1.Please provide procedure name and date 2.Please explain in detail what was the issue with the device 3.Were there any patient consequences? if yes, please explain in detail.Analysis summary: one dispensed suture and a detached needle product code pdp2017 were returned to ethicon inc for analysis.Upon visual inspection of the sample received, the swage area and attachment of the needle were observed cracked barrel.The cracked barrel defect has been correlated to the manufacturing process.Based on the information currently available, a cracked barrel needle was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Additionally, thirty-two packets of product code pdp2017 were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection to the sample no external damages were observed on the packet.In order to evaluate the conditions of the returned samples, all packets were opened.The swage area and attachment of seventeen needles, were observed cracked barrel defect.In two samples, the swage area and attachment of the needle were observed cracked barrel with a needle part separated from the needle body.In thirteen samples the swage and attachment area were noted to be as expected.The needles were intact and no damages, breakage on body, tip or swage area were observed during evaluation.The cracked barrel and breakage needle defects have been correlated to the manufacturing process.Based on the information currently available, the cracked barrel and breakage needle were identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot number paz813/ pdp2017h40 and no non-conformances related to the reported complaint condition were identified.The manufacturing standards were met prior to the release of this batch.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m.Related events captured via: 2210968-2021-07836, 2210968-2021-07838 and 2210968-2021-07839.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date in 2021 and suture was used.An unspecified quality issue was observed.There were no patient consequences reported.Additional information has been requested.

Manufacturer Narrative

(b)(4) date sent to the fda: 9/21/2021 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.The following additional information was provided: the product was used in an animal surgery.¿ trade name - irgacare® ¿ active ingredient(s) ¿ triclosan ¿ dosage form ¿ suture/solid/parenteral ¿ strength ¿ = 2360 ¿g/m.

• Brand Name: PDS PLUS VIO 27IN USP0
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12391484
• MDR Text Key: 268925010
• Report Number: 2210968-2021-07837
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• PMA/PMN Number: K061037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: PDP2017H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Date Manufacturer Received: 09/01/2021
• Patient Sequence Number: 1