MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 1/4 IN ID X 10 FT L(.64CM IDX3.05MTR L); TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Model Number	0036290
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 one 0036290 returned unopened in original packaging.The lot number of the device ¿ 202003104 was verified via returned packaging.A visual inspection found a fold in the seal.A functional inspection was then performed, and the devices were dye leak tested per policy.The dye leak testing indicated the packaging had an insufficient heat seal, the dye was flowing through the folds in the seal.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 this is the only complaint for this lot number and failure mode.(b)(4).Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.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 # 0036290, lot 202003104, 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: 1/4 IN ID X 10 FT L(.64CM IDX3.05MTR L)
• 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
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12758902
• Report Number: 3007305485-2021-00408
• Device Sequence Number: 3343293
• Product Code: BYY
• UDI-Device Identifier: 10653405000471
• UDI-Public: (01)10653405000471(17)250309(10)202003104
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2021

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
• Device Expiration Date: 03/09/2025
• Device Model Number: 0036290
• Device Catalogue Number: 0036290
• Device Lot Number: 202003104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic