MAUDE Adverse Event Report: CONMED MEXICO INSUFFLATION TUBE, OPEN CONN.

Catalog Number 60-6050-097

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported device was received with original unopened product packaging.Label verification and visual examination were performed.The device was observed to have a tear in the packaging's poly material.Due to the location and appearance of the defect area, it is likely that the device caused the damage to the packaging.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of this product.The products released for distribution were found to have met all specifications prior to shipment.Of the lot containing (b)(4) units, no other complaints for this lot have been received.A two-year review of complaint history revealed 3 similar complaints for a total of 13 devices.During this same time frame, (b)(4) devices have been manufactured and shipped worldwide.Should all devices have been confirmed this would make the rate of occurrence of this failure (b)(4).This reported packaging issue was obvious to the distributor, prompting the return of the device for evaluation.There was no patient involvement.As with all medical devices, examination of the product occurs multiple times prior to use.Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor in (b)(6) rejected one (b)(4) insufflation tube due to damaged packaging.In this instance, there was no patient involvement as the packaging anomaly was discovered during inspection prior to distribution to an end-user.The report is raised on the basis of a device malfunction with potential for injury with recurrence.

• Brand Name: INSUFFLATION TUBE, OPEN CONN.
• Type of Device: INSUFFLATION TUBE
• Manufacturer (Section D): CONMED MEXICO; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX
• Manufacturer (Section G): CONMED MEXICO; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 7331881
• MDR Text Key: 102219711
• Report Number: 3007305485-2018-00065
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 00653405038309
• UDI-Public: (01)00653405038309(17)220208(30)1(10)201702095
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K943954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/08/2022
• Device Catalogue Number: 60-6050-097
• Device Lot Number: 201702095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1