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

Device Problem Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the temp sensing foley consistently read a temperature higher than the patient's actual temperature.Health professionals took temperatures rectally and orally that were lower than what the temp-sensing foley read.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿sensor wire breaks thermistor cracks or breaks¿ with a potential root cause of ¿sensor wire too weak or thermistor chip too weak¿.The lot number is unknown therefore the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard/bd is unable to determine the associated labeling to review.H11:section a through f - the information provided by bd represents all of 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.H3 other text : the device was not returned.

Event Description

It was reported that the temp sensing foley consistently read a temperature higher than the patient's actual temperature.Health professionals took temperatures rectally and orally that were lower than what the temp-sensing foley read.

• Brand Name: UNKNOWN SILICONE TEMP-SENSING CATHETER
• Type of Device: UNK TEMP SENSING FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9745361
• MDR Text Key: 184146889
• Report Number: 1018233-2020-01253
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1