MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORPORATION MEDLINE INDUSTRIES, INC.; CARDIAC CATHETERIZATION KIT

Model Number	ECVC6225A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nursing was assisting physician with left ij triple lumen catheter placement.When the physician opened the suture packaging to secure the newly placed line, the packet was empty.The suture was unable to be located in the rest of the kit.No known harm to patient.Extra equipment needed to be obtained to complete the procedure.Minor delay.Manufacturer response for cardiac catheterization kit, medline industries, inc.(per site reporter).

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 100 centurion way; williamston MI 48895
• MDR Report Key: 16232732
• Report Number: 16232732
• Device Sequence Number: 6972373
• Product Code: OES
• UDI-Device Identifier: 10653160333418
• UDI-Public: (01)10653160333418(10)2022100590(17)240731
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/13/2023
• Report Date (Section F): 01/13/2023

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: ECVC6225A
• Device Catalogue Number: ECVC6225A
• Device Lot Number: 2022100590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/13/2023