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

Model Number DYNJ46419C

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2019

Event Type  malfunction  

Event Description

Staff discovered after case that femoral drape showed signs of leaking.Manufacturer response for custom cardiac catheter tray, (brand not provided) (per site reporter).Reached out to medline rep this morning and waiting to a reply.

• Brand Name: MEDLINE CARDIAC CATHETER TRAY
• Type of Device: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1204 townline rd; 1 medline place; mundelein IL 60060
• MDR Report Key: 8802723
• MDR Text Key: 151450162
• Report Number: 8802723
• Device Sequence Number: 1
• Product Code: OES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DYNJ46419C
• Device Catalogue Number: DYNJ46419C
• Device Lot Number: 19BBT045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2019
• Date Report to Manufacturer: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1