MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number J339H

Device Problems Delivered as Unsterile Product (1421); Product Quality Problem (1506)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested, and the following was obtained: any hole, tear, or puncture that compromises sterility.? no further information is available since the sterile package (aluminum package) was not returned.Open or incomplete seal that exposed the tip side? please see above.Do you have any pictures for visual analysis? some photos were uploaded.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

Event Description

It was reported that during an unknown surgery on (b)(6) 2021, before being used on the patient, the needle in the sot package was found to be inserted in the opposite direction, and although the swage part side was usually exposed, the needle tip side was exposed.There was no patient consequence reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 5/24/2021.H6 component code: g07002 - no device problem found.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, 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.H3 evaluation: investigation summary: visual inspection was conducted on the pictures received.Visual analysis of video received determined that one opened sample of product code j339h could be observed.A detached needle parked in opposite direction and with mark in the body needle could be observed.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.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample of product code j339 was received for evaluation.Incorrect needle park defect could be observed in the sample.The visual inspection concluded that the needle was inserted in the opposite direction.In addition, no marks of the swage area were observed, the needle was unused.The incorrect needle park defect has been correlated to the manufacturing process.According to the procedures is a class 1 defect.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.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.Based on the information currently available, the incorrect needle park was identified during the investigation of the sample received.This product issue will be addressed through quality system.

• Brand Name: VCL CT BRD VIO 27IN 2-0 S/A CT-1
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11735359
• MDR Text Key: 248768917
• Report Number: 2210968-2021-03868
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031039018
• UDI-Public: 10705031039018
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: J339H
• Device Catalogue Number: J339H
• Device Lot Number: QKMJCQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1