MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT EXCEL INSUFFLATION TUBING

Catalog Number	60-6050-097
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the device found a stressed area of tyvek near the filter component of the device.There did not appear to be any abnormalities with the seal on the outer edge of the packaging.Dye leak testing was completed to determine if the stressed tyvek caused an opening.Dye leak testing found that the stressed area did cause a breach in the packaging, allowing the dye to leak through the packaging.There was no packaging problem with the seal surrounding the device.The hole in the tyvek allowing the dye leak through the packaging evidences a breach in the sterility of the device.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 was found to have met all specifications prior to shipment.A lot history review was conducted and found this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 24 devices for this family and failure mode.During the same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised; it is standard medical practice to inspect all medical devices prior to use.
Event or Problem Description
The distributor rejected the 60-6050-097, tubing for damage to packaging.After further assessment and evaluation a breach of sterility was found by using the dye leak testing this report is being raised on the basis of device malfunction with potential for injury upon reoccurrence.

• Brand Name: EXCEL INSUFFLATION TUBING
• Common Device Name: INSUFFLATION TUBING
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 8107318
• Report Number: 3007305485-2018-00256
• Device Sequence Number: 13962610
• Product Code: HIF
• UDI-Device Identifier: 00653405038309
• UDI-Public: (01)00653405038309(17)230129(30)1(10)201801305
• 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): 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/29/2023
• Device Catalogue Number: 60-6050-097
• Device Lot Number: 201801305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1