MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 1/4"(6.4MM)X6'(1.8M) W/M&F CO; TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Model Number	0037860
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
One device was received in unopened, original packaging.The reported catalog number and lot number were verified.Inspection of the device found that a breach was in the seal area.Due to the location and shape of the breach, it is likely that the device pushed from inside of the packaging and breached the seal.The breach was caused from the inside out.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 a total of 40 complaints, regarding 76 devices, for this device family and failure mode.During this same time frame 15,355,050 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.000005.It is standard medical practice to inspect all device prior to use.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 0037860, 1/4"(6.4mm)x6"(1.8m) w/m&f co, device due to an "insufficient heatseal".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: 1/4"(6.4MM)X6'(1.8M) W/M&F CO
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 7620306
• Report Number: 3007305485-2018-00148
• Device Sequence Number: 1383675
• Product Code: BYY
• UDI-Device Identifier: 10653405000624
• UDI-Public: (01)10653405000624(17)220807(10)201708084
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 06/20/2018

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: 08/07/2022
• Device Model Number: 0037860
• Device Catalogue Number: 0037860
• Device Lot Number: 201708084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1