MAUDE Adverse Event Report: MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR TERUMO CARDIOVASCULAR; RIGID INTRACARDIAC SUCKER

Model Number	4300S
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer a pouch was unsealed at the bottom.This was identified prior to use.No injury/death was reported.

• Brand Name: TERUMO CARDIOVASCULAR
• Common Device Name: RIGID INTRACARDIAC SUCKER
• Manufacturer (Section D): MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR; 2140 oak industrial drive ne; grand rapids MI 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: 17013730
• Report Number: 3017540705-2023-00001
• Device Sequence Number: 20591064
• Product Code: GCX
• UDI-Device Identifier: 00817278011399
• UDI-Public: 00817278011399
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K971022
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 05/26/2023

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 Model Number: 4300S
• Device Catalogue Number: 4300S
• Device Lot Number: 06217-113022
• 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: 04/27/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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