MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TEMPERATURE SENSING FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Lot Number 20EBS824

Device Problems Break (1069); Loose or Intermittent Connection (1371); Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 10/30/2020

Event Type  malfunction  

Event Description

Medline temperature sensing foleys not secure or working well.Temp sensing probes in new product are easily knocked loose and falls out and continuous core temperature monitoring unable to be easily be performed in critically ill patients.Patient reached his cord and probe easily fell out unintentionally and cable was snapped.Defective equipment removed from patient use; but unable to monitor continuous temperature.

• Brand Name: TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 10828700
• MDR Text Key: 215930418
• Report Number: 10828700
• Device Sequence Number: 1
• Product Code: EZL
• 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: 10/30/2020

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
• Device Operator: No Information
• Device Lot Number: 20EBS824
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA