MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT ULTRACLEAN ELEC: 1" NDLE; EXT IN; ULTRACLEAN ELECTRODES

Catalog Number	139105EXT
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported unused devices were returned for evaluation in original unopened packaging.Label verification and visual inspection were performed.A hole was found in the poly material, adjacent to the device's proximal electrode, of both packages.These defects resulted in a sterile breach and were likely caused by the device after the sealing process.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 2400 units, no prior complaints have been received.A two-year review of complaint history revealed seven similar prior complaints.During this same time frame, 251,600 devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure 0.003 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 or Problem Description
The distributor in (b)(6) reported a "scratch" on the sterile pouch of two electrode devices.There was no patient involvement as these defects were discovered during incoming inspection.This report is raised on the basis of a sterility breach found during the device evaluation.

• Brand Name: ULTRACLEAN ELEC: 1" NDLE; EXT IN
• Common Device Name: ULTRACLEAN ELECTRODES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua 31136 ; MX 31136
• MDR Report Key: 7268113
• Report Number: 3007305485-2018-00028
• Device Sequence Number: 2117183
• Product Code: GEI
• UDI-Device Identifier: 20653405033254
• UDI-Public: (01)20653405033254(17)210714(30)50(10)201607154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K991855
• 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): 02/13/2018

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: Other
• Device Expiration Date: 07/14/2021
• Device Catalogue Number: 139105EXT
• Device Lot Number: 201607154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1