MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number J260H

Device Problem Product Quality Problem (1506)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that when a new box of suture was opened in 2020, a smashed bug, looks like a fly, on one of the inner suture packages was found.There were no adverse consequences for the patient.

Manufacturer Narrative

Date sent to the fda: 01/22/2021.A manufacturing record evaluation was performed for the finished device lot number qhmbld, and no non-conformances related to the reported complaint condition were identified.Additional h-3 summary: photo analysis: two pictures were received for evaluation.Upon to visual inspection of the pictures, a labeled winding former with a foreign matter of product code j260h05, qhmbld could be observed.No conclusion could be reached as on what caused the reported complaint, since the sample was not returned for analysis at that time.Actual sample: a paper lid and a winding former with a needle/suture combination of product code j260, lot # qhmbld were received for evaluation.During the visual inspection of the sample, a foreign matter (insect dead) could be observed on the paper lid.The foreign matter defect has been correlated to the manufacturing process.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: VCL CT BRD UD 27IN 0 S/A CT-1
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11083928
• MDR Text Key: 224389231
• Report Number: 2210968-2020-10346
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031038332
• UDI-Public: 10705031038332
• Combination Product (y/n): N
• PMA/PMN Number: K022269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: J260H
• Device Catalogue Number: J260H
• Device Lot Number: QHMBLD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Date Manufacturer Received: 12/30/2020
• Patient Sequence Number: 1