MAUDE Adverse Event Report: MC3 INC. MC3; CARDIOVASCULAR CANNULA

Model Number	7072
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This particular device could not be examined because it was not returned.10 devices from the identical lot were tested and found to meet the 20 lb specification for bond strength.A thorough investigation of this issue was completed that did not reveal any significant finding related to the manufacturing of this lot or any other soft-flow lot that would indicate a cause of bond failure other than forces greater than the specified bond strength.
Event or Problem Description
The customer reported a malfunction to the distributor.Before insertion of the cannula, during set up of the preoperative procedures, the connection between the body and connector was inspected and found to be loose.

• Brand Name: MC3
• Common Device Name: CARDIOVASCULAR CANNULA
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter, mi
• MDR Report Key: 10040088
• Report Number: 3011468686-2020-00002
• Device Sequence Number: 16923359
• Product Code: DWF
• UDI-Device Identifier: 10854916006369
• UDI-Public: 10854916006369
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2020

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 7072
• Device Catalogue Number: 7072
• Device Lot Number: 1907116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1