MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ABC R/U HANDPIECE NOZZLE

Catalog Number 130343

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor in (b)(6) rejected 130343, abc hand piece nozzle, due to an "insufficient heat seal".In this instance, there was no patient involvement as the packaging anomaly was discovered during incoming inspection prior to distribution to an end-user.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Received three 130343 in unopened original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach.Performed a functional inspection, the devices were dye leak tested, which indicated that the packaging had an insufficient heat seal on two out of the three packages.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been 8 complaints regarding 11 devices for this device family and failure mode.During the same time frame 201,218 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.00005 per the instructions for use, the user is advised the following; - conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ABC R/U HANDPIECE NOZZLE
• Type of Device: NOZZLE
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 9890252
• MDR Text Key: 202726544
• Report Number: 3007305485-2020-00119
• Device Sequence Number: 1
• Product Code: HAM
• Combination Product (y/n): N
• PMA/PMN Number: K871435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/14/2023
• Device Catalogue Number: 130343
• Device Lot Number: 201808154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1