MAUDE Adverse Event Report: DEGANIA SILICONE LTD MON-A-THERM¿ FOLEY CATHETER WITH TEMPERATURE SENSOR; TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER

Model Number 14 FRENCH

Device Problems High Readings (2459); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

Since the actual sample was not available and the lot number is unknown, we do not have enough data to confirm the issue with the product and perform proper investigation.The incorrect reading of temperature could be caused by connection issues between our catheter and the monitor.

Event Description

According to the reporter, the temperature sensor was defective.The patient has had fever for many days at 38-39 celsius.Antibiotic was changed, and blood culture was taken.Patient's fever has been tried to get down without success.The patient has said they don't feel feverish the day before, so temperature was checked with ear thermometer and it was lower than what the device showed.The temperature was check on different date it showed 2 degrees more fever than when taken with armpit and from ear.There was no patient injury.

• Brand Name: MON-A-THERM¿ FOLEY CATHETER WITH TEMPERATURE SENSOR
• Type of Device: TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER
• Manufacturer (Section D): DEGANIA SILICONE LTD; degania bet; jordan valley; degania bet, 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA SILICONE LTD; degania bet; jordan valley; degania bet, 15130 00; IS 1513000
• Manufacturer Contact: katia kayam ; degania bet; jordan valley; degania bet, 15130-00 ; IS 1513000
• MDR Report Key: 9999344
• MDR Text Key: 200442809
• Report Number: 8030107-2020-00005
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K063442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2020

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: Health Professional
• Device Model Number: 14 FRENCH
• Device Catalogue Number: 102201101480TY
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1