MAUDE Adverse Event Report: MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR SURGE CARDIOVASCULAR; FEMORAL VENOUS CANNULA

Model Number	FEM-V1028
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer one (1) unsealed pouch at the bottom.This was identified prior to use.No injury/death was reported.

• Brand Name: SURGE CARDIOVASCULAR
• Common Device Name: FEMORAL VENOUS CANNULA
• Manufacturer (Section D): MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR; 2140 oak industrial drive ne; grand rapids 49505
• Manufacturer (Section G): MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR; 2140 oak industrial drive ne; grand rapids MI 49505
• Manufacturer Contact: james wisniewski ; 2140 oak industrial drive ne; grand rapids, MI 49505 ; 6168211323
• MDR Report Key: 20763290
• Report Number: 3017540705-2024-00003
• Device Sequence Number: 18310653
• Product Code: DWF
• UDI-Device Identifier: 00817278012389
• UDI-Public: 00817278012389
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K081933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: 02/17/2026
• Device Model Number: FEM-V1028
• Device Catalogue Number: FEM-V1028
• Device Lot Number: 06510-021823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2023
• 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