MAUDE Adverse Event Report: MC3 INC. CRESCENT JUGULAR DUAL LUMEN ECMO CATHETER 28 FR; DUAL LUMEN ECMO CANNULA

Model Number	70128
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet returned to manufacturer.The reported problem has not yet been confirmed.Investigation is inconclusive at this time.
Event or Problem Description
After decannulation of the crescent catheter, the perfusionist noticed a small fracture just beneath the gold suture ring.There was no effect to the patient nor any additional interventions performed.

• Brand Name: CRESCENT JUGULAR DUAL LUMEN ECMO CATHETER 28 FR
• Common Device Name: DUAL LUMEN ECMO 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: 15093025
• Report Number: 3011468686-2022-00009
• Device Sequence Number: 11771057
• Product Code: PZS
• UDI-Device Identifier: 10854916006802
• UDI-Public: 10854916006802
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2022

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: 02/28/2023
• Device Model Number: 70128
• Device Catalogue Number: 70128
• Device Lot Number: 2001166
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown