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

Model Number 129416M

Device Problem Partial Blockage (1065)

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

Event Date 01/25/2023

Event Type  malfunction  

Event Description

It was reported that the foley catheter was inserted and when there was no urine a couple of hours later, the nurse attempted to flush the foley and was unable to.The foley was removed, and they attempted to flush the foley after it was removed.That was when the nurse realized that the foley was defective, and this has been happened on (b)(6) (pcn# a319416am and lot# nggv5269).Stated that their intensive care unit (icu) team had recently shared with staff that for the past few weeks, they have had about half a dozen patients with temperature sensing foleys where the temperatures did not match the patient's clinical condition.This prompted them to check a secondary source such as rectal or esophageal and there was a 4+ degree difference between the two leading them to suspect the temperature sensing foley was faulty and this has been happened on wellstar douglas (pcn# a319416am and lot# unk ).Per follow-up via email on 08feb2023, it was reported that there was no patient harm.

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 foley catheter was inserted and when there was no urine a couple of hours later, the nurse attempted to flush the foley and was unable to.The foley was removed, and they attempted to flush the foley after it was removed.That was when the nurse realized that the foley was defective, and this has been happened on wellstar cobb (pcn# a319416am and lot# nggv5269).Stated that their intensive care unit (icu) team had recently shared with staff that for the past few weeks, they have had about half a dozen patients with temperature sensing foleys where the temperatures did not match the patient's clinical condition.This prompted them to check a secondary source such as rectal or esophageal and there was a 4+ degree difference between the two leading them to suspect the temperature sensing foley was faulty and this has been happened on wellstar douglas (pcn# a319416am and lot# unk ).Per follow-up via email on 08feb2023, it was reported that there was no patient harm.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be ¿ biological deposits -physiological obstruction, blocked by clots, tubing design (lumen id undersized)".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: "bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip syringes (fig.1b).1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.(fig.2) 3.Using aseptic technique, position the syringe in the center of the sampling port.Press the syringe firmly and twist gently to access the sampling port.(fig.3) 4.Slowly aspirate urine sample into syringe and remove syringe from sample port.5.Unkink tubing if necessary and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab." h11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: FOLEY 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: 16371311
• MDR Text Key: 309481056
• Report Number: 1018233-2023-00867
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039775
• UDI-Public: (01)00801741039775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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
• Device Model Number: 129416M
• Device Catalogue Number: 129416M
• Device Lot Number: NGGV5269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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