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

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 11/22/2023

Event Type  malfunction  

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.

Event Description

It was reported that the nurse stated that the neonate pad had become soaked with water.Should it be continuing to use it.Also, they noted that the esophageal probe was out of range yesterday and the patient was having trouble reaching target in an arctic sun device.The water temperature (wt) was 10c for an extended period last night.They thought the device should alarm in these cases.Advised that if the hydrogel was compromised this could affect therapy.If the hydrogel was still sticky then therapy should not be impacted, however they should keep a close eye on the patient skin and consider changing pad if clinically necessary.Explained they could walk them through pausing the therapy and changing out the pad as they were concerned about stopping the therapy.Explained there were both an alert and an alarm for extended periods of cold water exposure and not in the room.Suggested to call from the room so they could check the event log.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.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.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.Corrections: h 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.H3 other text : the device was not returned.

Event Description

It was reported that the nurse stated that the neonate pad had become soaked with water.Should it be continuing to use it.Also, they noted that the esophageal probe was out of range yesterday and the patient was having trouble reaching target in an arctic sun device.The water temperature (wt) was 10c for an extended period last night.They thought the device should alarm in these cases.Advised that if the hydrogel was compromised this could affect therapy.If the hydrogel was still sticky then therapy should not be impacted, however they should keep a close eye on the patient skin and consider changing pad if clinically necessary.Explained they could walk them through pausing the therapy and changing out the pad as they were concerned about stopping the therapy.Explained there were both an alert and an alarm for extended periods of cold water exposure and not in the room.Suggested to call from the room so they could check the event log.

• Brand Name: UNKNOWN LATEX TEMP-SENSING CATHETER
• Type of Device: UNKNOWN LATEX TEMP-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: 18302712
• MDR Text Key: 330829129
• Report Number: 1018233-2023-08864
• 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: 12/22/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 12/23/2023
• Supplement Dates FDA Received: 12/27/2023
• 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