MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 10' INSUFF TUBING W/O-RING; INSUFFLATOR, LAPAROSCOPIC

Model Number	60-6050-098
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received in original, unopened packaging.The reported catalog and lot numbers were verified.Visual inspection of the device found a stressed area of tyvek in close proximity to 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.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 8 complaints, regarding 12 devices, for this device family and failure mode.During this 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 the following: - that the device is delivered sterile per markings on the device 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) reported a "tear" on the sterile pouch of the 60-6050-098 device.This would be an obvious defect to the user and was therefore not deemed a reported device failure.However, the complaint device was returned to conmed for evaluation and a sterile breach was found which was likely caused by the device.No patient involvement as this defect was found during incoming inspection.This incident will be reported as a device malfunction with potential for injury.

• Brand Name: 10' INSUFF TUBING W/O-RING
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 8125518
• Report Number: 3007305485-2018-00268
• Device Sequence Number: 1913217
• Product Code: HIF
• UDI-Device Identifier: 10653405012009
• UDI-Public: (01)10653405012009(17)220925(10)201709264
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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: 09/25/2022
• Device Model Number: 60-6050-098
• Device Catalogue Number: 60-6050-098
• Device Lot Number: 201709264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1