MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; CATHETER CARE TRAY

Model Number URO170816T

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2021

Event Type  malfunction  

Event Description

During routine foley care, foley catheter dislodged.Upon further inspection, balloon was not intact.

• Brand Name: MEDLINE
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 12554211
• MDR Text Key: 274028173
• Report Number: 12554211
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URO170816T
• Device Catalogue Number: URO170816T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2021
• Date Report to Manufacturer: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA