MAUDE Adverse Event Report: ETHICON INC. PDSPLUS VIO 8X45 M3 CTB-1 CR::-HOT ROOM 2-0; SUTURE, SURGICAL, ABSORBABLE

Catalog Number PDPB739Z

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 05/17/2021

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.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4).The following information was requested, but unavailable: lot number? trade name: irgacare®.Active ingredient(s): triclosan.Dosage form: suture/solid/parenteral.Strength: = 2360 g/m.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, when removing paper after the package was opened, it was found that there had been a hair.There were no adverse consequences to the patient.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: 7/20/2021.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 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.H6 component code: g07002 ¿ conforming device.Additional h3 investigation summary: one winding former with eight needle/suture combinations of product code pdpb739z was returned for analysis.The paper lid and the foil packaging were not received.Upon initial inspection to the sample no foreign matter or defects were observed on the sample received.The manufacturing records couldn't be reviewed as the batch number is unknown.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.

• Brand Name: PDSPLUS VIO 8X45 M3 CTB-1 CR::-HOT ROOM 2-0
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11991678
• MDR Text Key: 259044689
• Report Number: 2210968-2021-05495
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: PDPB739Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 06/23/2021
• Patient Sequence Number: 1