MAUDE Adverse Event Report: MC3 INC. MC3 SOFT-FLOW AORTIC CANNULA; ARTERIAL CANNULA

Model Number	6394
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device was not returned, the results of the investigation could not confirm the direct cause of the connector separating from the cannula body.The customer may have added force to break the connector bond but this is unknown.The lot record review indicates that all 6394 devices of lot 1911156 met specification.The tubing had been removed from the barb connector which requires force.An in-depth review of production data, trend data, records, and testing of other soft-flow devices from this lot did not uncover any root cause of bond strength variation that could have caused the malfunction.With excessive force it is possible to break the glue joint while disconnecting tubing from the circuit.A force may have been applied to the bond joint greater than the specification limit.The investigation of this issue was completed that did not reveal any significant finding related to the manufacture 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
Distributor received information that after use of a mc3 6394 soft flow cannula for cardiopulmonary bypass surgery, it was reported that the connector was detached.The connector broke off the cannula body when disconnecting from the extracorporeal circuit.This occurred post surgery.There was no patient impact associated with this event.

• Brand Name: MC3 SOFT-FLOW AORTIC CANNULA
• Common Device Name: ARTERIAL CANNULA
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer (Section G): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer Contact: martha rumford ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 14364431
• Report Number: 3011468686-2022-00006
• Device Sequence Number: 4613419
• Product Code: DWF
• UDI-Device Identifier: 10854916006321
• UDI-Public: 10854916006321
• Combination Product (Y/N): N
• Initial Reporter Country: BO
• PMA/510(K) Number: K132451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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: 11/30/2022
• Device Model Number: 6394
• Device Catalogue Number: 6394
• Device Lot Number: 1911156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown