MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN LATEX TEMP-SENSING CATHETER; UNKNOWN TEMPERATURE SENSING FOLEY CATHETER

Catalog Number UNKNOWN

Device Problems Disconnection (1171); Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to "sensor wire too weak".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.As the product catalog number and lot number are unknown, a labeling review cannot be completed.

Event Description

It was reported that the arctic sun device with s/n (b)(4) in the shop gave an incorrect patient temperature fatal error.Checked event log which showed an alert 11 (patient temperature 1 below low patient alert), an alarm 15 (unable to obtain a stable patient temperature) and an alert 50 (patient temperature erratic).Asked biomed to connect a temperature monitor key.The temperature reads as 37c and was stable if the temperature in cable was flexed.Explained that the unstable temperature might have been caused by the patient's probe.Forwarded to technical support.The technical support checked out the arctic sun device and accessories and confirmed that the issue was not a device related.The issue was likely related to the probe dislodgment or connection.Per follow up via biomed dennis on 28jul2020, technical support called and did a calibration on the arctic sun device together and it was successful.No further issue with device.Device is back in service.

• Brand Name: UNKNOWN LATEX TEMP-SENSING CATHETER
• Type of Device: UNKNOWN TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 11325244
• MDR Text Key: 233192600
• Report Number: 1018233-2021-80015
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2021

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 Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2021
• Initial Date FDA Received: 02/12/2021
• 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