MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TOTAL 1-LAYER TRAY; CATHETER CARE TRAY

Catalog Number UR04PVCPC14

Device Problem Unintended Ejection (1234)

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

Event Date 01/12/2020

Event Type  malfunction  

Event Description

Patient had a straight catheter and bag started to leak from the two venting holes at the top of the bag.

• Brand Name: TOTAL 1-LAYER TRAY
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9726637
• MDR Text Key: 179959169
• Report Number: 9726637
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UR04PVCPC14
• Device Lot Number: 96919090001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA