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

Catalog Number 129414M

Device Problems Erratic or Intermittent Display (1182); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)

Event Date 04/24/2019

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 temperature gradually rises after insertion, and measures 42 ° c after about 15 minutes during the operation.It was suspected that the patient had a malignant high fever and discontinued the operation.The catheter measured the normal temperature as it was used at the rectum.

Event Description

It was reported that the temperature gradually rises after insertion, and measures 42 ° c after about 15 minutes during the operation.It was suspected that the patient had a malignant high fever and discontinued the operation.The catheter measured the normal temperature as it was used at the rectum.Per additional information received from the international business center on 16-may-2019, the hospital confirmed that the patient experienced a high fever and discontinued the operation.It was unknown if the patient continued to use the catheter when the temperature was normal.

Manufacturer Narrative

The reported event was unconfirmed.The evaluation found that the returned sample met specification.Observed reading as usual on the returned sample.The catheter was dissected and found the wire was in good condition.The exact time of how and when problem occurred could not be determined.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "1) do not stretch catheter as damage to or dislodgement of lead wire as temperature probe may cause improper temperature measurement.2) when endoelectric surgery is performed, care should be taken to prevent burns in the local tissue.3) do not wet the lead wire and the junction with extension cable.4) this device is compatible only with monitors requiring ysi 400-series type temperature probes.".

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8612592
• MDR Text Key: 145236673
• Report Number: 1018233-2019-02572
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2023
• Device Catalogue Number: 129414M
• Device Lot Number: 8LE7130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1