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

Catalog Number	60-6050-097
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 packagings 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, only one other complaint for this lot number and failure mode has occurred.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 or Problem 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.
• Common Device Name: INSUFFLATION TUBE
• Manufacturer (Section D): CONMED MEXICO; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX
• MDR Report Key: 7331954
• Report Number: 3007305485-2018-00064
• Device Sequence Number: 147984
• Product Code: HIF
• UDI-Device Identifier: 00653405038309
• UDI-Public: (01)00653405038309(17)210606(30)1(10)201606074
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/06/2021
• Device Catalogue Number: 60-6050-097
• Device Lot Number: 201606074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1