MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 1/4IN (6.4MM) X 6 (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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this report is being resubmitted following an unsuccessful submission attempt on 2021-08-03 due to a system error.Reported event is confirmed.Customer event ¿insufficient heatseal¿ was confirmed based on device evaluation.Eleven 0037860 returned unopened in original packaging.The lot number of the devices ¿ 202002124 was verified.A visual inspection found areas on the clear side of the packaging of seven devices separating from the paper side causing a gap in the seal.Open holes were found on the packaging of three devices and device was encroaching into the packaging of one device.A functional test was performed, the eight devices without an obvious breach in the seal was dye leak tested.Seven of the eight devices had an insufficient heat seal.One did not have any defects.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 two-year lot history review was conducted and found a total of 3 similar events involving 35 devices for this lot number.A two-year review of complaint history revealed there has been a total of 38 complaints, regarding 91 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: conmed encourages the inspection of all medical equipment, labeling and packaging prior to use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
During incoming inspection, the distributor rejected this device, 0037860, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 1/4IN (6.4MM) X 6 (1.8M) W/M & F CO
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12385848
• Report Number: 3007305485-2021-00334
• Device Sequence Number: 4892076
• Product Code: BYY
• UDI-Device Identifier: 10653405000624
• UDI-Public: (01)10653405000624(17)250210(10)202002124
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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: 02/10/2025
• Device Model Number: 0037860
• Device Catalogue Number: 0037860
• Device Lot Number: 202002124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1