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

Device Problems Erratic or Intermittent Display (1182); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2023

Event Type  malfunction  

Event Description

It was reported that the patient on therapy and arctic sun device kept beeping with no message.Probe came out earlier and device alarmed, but it has been replaced.Walked through stop therapy and drain pads.Powered off and back on.Selected continue current patient and start.Device was no longer beeping.Advised to call back with any additional issues.Patient temperature (pt) was 36.8c, targeted temperature (tt) was 36.5c, flow rate (fr) was 2.7l/m.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Manufacturer Narrative

Upon further review, bd has determined that this mdr is not reportable.Section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the patient on therapy and arctic sun device kept beeping with no message.Probe came out earlier and device alarmed, but it has been replaced.Walked through stop therapy and drain pads.Powered off and back on.Selected continue current patient and start.Device was no longer beeping.Advised to call back with any additional issues.Patient temperature (pt) was 36.8c, targeted temperature (tt) was 36.5c, flow rate (fr) was 2.7l/m.

• Brand Name: UNKNOWN LATEX TEMP-SENSING CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18502207
• MDR Text Key: 332766945
• Report Number: 1018233-2024-00106
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• 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
• Patient Outcome(s): Other