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

Model Number	129416
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the temperature steadily climbed from 37c to 41c in the sensica device over a few hours while using the temperature sensing foley catheter.Nurse stated that the axillary and oral temperature did not rise.The nurse switched out the sensica unit and temperature cables and still saw a similar 41c reading.Later the patient needed to go to surgery so both sensica units were given to the onsite team and tested with temperature keys, and each read the temperature keys correctly.The nurse put the patient on a third sensica system and still read 41c after surgery.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the temperature steadily climbed from 37c to 41c in the sensica device over a few hours while using the temperature sensing foley catheter.Nurse stated that the axillary and oral temperature did not rise.The nurse switched out the sensica unit and temperature cables and still saw a similar 41c reading.Later the patient needed to go to surgery so both sensica units were given to the onsite team and tested with temperature keys, and each read the temperature keys correctly.The nurse put the patient on a third sensica system and still read 41c after surgery.
Event or Problem Description
It was reported that the temperature steadily climbed from 37c to 41c in the sensica device over a few hours while using the temperature sensing foley catheter.Nurse stated that the axillary and oral temperature did not rise.The nurse switched out the sensica unit and temperature cables and still saw a similar 41c reading.Later the patient needed to go to surgery so both sensica units were given to the onsite team and tested with temperature keys, and each read the temperature keys correctly.The nurse put the patient on a third sensica system and still read 41c after surgery.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿insufficient seal¿.It is unknown whether the device had met relevant specifications.The product was used for diagnostics purposes.It was unknown whether the product had caused the reported failure.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." 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.

• Brand Name: BARDEX® I.C. TEMPERATURE-SENSING FOLEY CATHETER
• Common Device Name: TEMPERATURE-SENSING 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13619479
• Report Number: 1018233-2022-00921
• Device Sequence Number: 4368721
• Product Code: MJC
• UDI-Device Identifier: 00801741039799
• UDI-Public: (01)00801741039799
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: 129416
• Device Catalogue Number: 129416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown