MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 10' INSUFF TUBING W/O-RING; PNEUMO INSUFFLATION

Catalog Number 60-6050-098

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported unused device was returned for evaluation in its original unopened package.Label verification and visual inspection were performed.The product was observed to have a tear in the packaging's poly material adjacent the product device's insufflation filter.This tear resulted in an opening in the packaging material and therefore the product's sterility was breached.Due to the location and appearance of the defect area, it is likely that the product 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 prior complaints have been received.A two-year review of complaint history revealed no prior similar complaints.During this same time frame, (b)(4) devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4) percent.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.The instructions for use (ifu) provides the following warning.-if packaging has been opened/damaged or altered, do not use the product and contact the manufacturer immediately.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor in (b)(6) reported "damage" on the sterile pouch of the device.There was no patient involvement as this defect was discovered during incoming inspection.This report is raised on the basis of a sterility breach found during the device evaluation.

• Brand Name: 10' INSUFF TUBING W/O-RING
• Type of Device: PNEUMO INSUFFLATION
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502 ; 7273995209
• MDR Report Key: 7323342
• MDR Text Key: 101986136
• Report Number: 3007305485-2018-00058
• Device Sequence Number: 1
• Product Code: HIF
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: 60-6050-098
• Device Lot Number: 201606294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1