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
The reported unused device was returned for evaluation in its original opened package.Label verification and visual inspection were performed.The device's short, straight seal was observed to have a seal area less than 1/4".Adjacent the device's defect area and male connector, the packaging was observed to have a tear.This defect resulted in a breach of sterility.Dye leak testing was performed on the defect seal area.Dye was observed to not penetrate the seal area.The packaging defect seal area was inspected for seal transfer.Seal transfer was observed to be less than 1/4" in the defect area.Due to the location and appearance of the defects, it is likely that the device was in the seal area during the sealing process and therefore a manufacturing related issue.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 3 complaints, regarding 4 devices, for this device family and failure mode.During this same time frame 15,573,370 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 0.0000003.It is standard medical practice to inspect all medical devices 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) reported a "tear" on the sterile pouch of this 0037860, surgical tubing.There was no patient involvement as this defect was discovered during incoming inspection.This report is raised on the basis of a malfunction due to a sterility breach found during the device evaluation.

• 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: 7490645
• Report Number: 3007305485-2018-00098
• Device Sequence Number: 16183090
• Product Code: BYY
• UDI-Device Identifier: 10653405000624
• UDI-Public: (01)10653405000624(17)220102(10)201701035
• 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): 05/07/2018

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: 01/02/2022
• Device Model Number: 0037860
• Device Catalogue Number: 0037860
• Device Lot Number: 201701035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1