MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; CARDIAC CATHETERIZATION KIT

Model Number	DYNJ82862A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Product-medline cath lab pack.The sterile blue wrap had a tear/hole when the plastic wrap was removed.Product not used due to compromised integrity.Manufacturer response for cardiac catheterization kit, medline industries, inc.(per site reporter).Will obtain.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 12001 general milton drive; laredo TX 78045
• MDR Report Key: 16529156
• Report Number: 16529156
• Device Sequence Number: 2620126
• Product Code: OES
• UDI-Device Identifier: 10195327245030
• UDI-Public: (01)10195327245030(17)20250930(10)22KBG750
• 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): 02/16/2023
• Report Date (Section F): 02/16/2023

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: DYNJ82862A
• Device Catalogue Number: DYNJ82862A
• Device Lot Number: 22KBG750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/16/2023