MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 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
Investigation of the customer's complaint of an insufficient heat seal leading to a breach in sterility has confirmed the reported issue.Conmed received nine #: (b)(4) returned unopened in original packaging, the reported catalog and lot numbers were verified.A visual inspection found three devices encroached into the seal.Two devices had holes in the seal.Two devices had gaps in the seal caused by the clear side of the packaging lifting slightly.The packaging of the two remaining devices did not have an obvious breach.A functional inspection was then performed, and the devices were dye leak tested per policy.The seven devices without open holes were dye leak tested which indicated four of seven had insufficient heat seals.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review found 2 events with a quantity of 20 units for this lot number and failure mode however, only 4 are confirmed a two-year review of complaint history revealed there has been a total of 37 complaints, regarding 77 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).Conmed encourages the inspection and/or test of all medical equipment 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, catalog # 0037860, lot 202002124, for a possible breach of sterility due to an insufficient heatseal.There was no contact with any patient as this was found during incoming inspection in (b)(6).The completion of the device evaluation confirmed an insufficient heatseal; therefore, this complaint meets the criteria for a reportable event.Due to the breach in sterility, this report is being raised as a 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; alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12385426
• Report Number: 3007305485-2021-00314
• Device Sequence Number: 4892071
• 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: No Information
• 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: 05/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• 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