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

Catalog Number	119416M
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that due to the silicone latex shortage, customer were now using latex temperature foley catheter and having issues with inaccuracy of temperature.Per additional information received via email on 08mar2024, both of these patients were severely ill and on ecmo.Biomedical engineering tested our cables with our simulators and said they were working properly.Provided lot numbers were (lot#nghx3351, lot#nghx4795).
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "sensor wire too weak".However, there was insufficient information to confirm this potential root cause.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "caution: this product contains natural rubber latex which may cause allergic reactions.Sterile: unless package is opened or damaged.Sterilized by ethylene oxide single use only do not resterilize warning: do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.Do not wipe catheter surface with organic solvents (such as alcohol).After use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Do not aspirate urine through drainage funnel wall.Caution: as with all temperature probes, in the presence of rf energy sources, local heating, temperature errors, and probe damage may occur.In medical use, unplug the temperature sensing catheter at the temperature monitor before activating electrosurgical or other types of direct coupled rf energy sources.Aggressive traction, particularly in the presence of suturing, is not recommended for 100 percentage silicone foley catheters.For urological use only valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, reseat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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.Note: compatible with appropriate 400 series temperature monitors.Do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box." udi format updated with available product information per gudid.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.

• Brand Name: BARDEX® LUBRICATH® 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20245349
• Report Number: 1018233-2024-05814
• Device Sequence Number: 20660990
• Product Code: EZC
• UDI-Device Identifier: 00801741046148
• UDI-Public: (01)00801741046148(11)231106(17)271130(10)NGHX3351
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: Lay User/Patient
• Device Catalogue Number: 119416M
• Device Lot Number: NGHX3351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• 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