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

Catalog Number	119318M
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the critical care nurses in an online survey that the patient experienced an adverse event directly caused and attributable to the usage of the device in 2-way 5cc lubrissil ic catheter temperature sensing and resulted in the following complications was leakage.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the critical care nurses reported in an online survey that the patient experienced and adverse event directly caused and attributable to the usage of the device in 2-way 5cc lubrissil ic catheter temperature sensing and the resulted in the following complications was leakage.Per additional information received via mail on (b)(6) 2024, stated that the respondent indicated the patient did required medical or surgical intervention and indicated surgery.
Event or Problem Description
It was reported that the critical care nurses reported in an online survey that the patient experienced and adverse event directly caused and attributable to the usage of the device temperature sensing foley catheter and the resulted in the following complications was leakage.Per additional information received via mail on (b)(6)2024, stated that the respondent indicated the patient did required medical or surgical intervention and indicated surgery.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Sterile unless package is opened or damaged.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.With bard® hydrogel and bacti-guard®* silver alloy coating warning: this product should never be connected to the temperature monitor or connected to a cable during an mri procedure.Failure to follow this guideline may result in serious injury to the patient.It is important to closely follow these specific conditions that have been determined to permit the examination to be conducted safely.Any deviation may result in a serious injury to the patient.Catheters should be replaced in accordance with the cdc guideline ¿guideline for prevention of catheter-associated urinary tract infection¿.At the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheter-related adverse effect, the catheter should be replaced.Caution: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone balloon foley catheters.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.If you notice slow or no deflation, re-seat 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 only with the bard criticore monitor, bard urotrack 224 monitor, and other 400-series temperature monitors.Interchangeability ± 0.2°c at 37°c.Caution: as with all temperature probes, in the presence of rf energy sources, local heating, temperature errors, and probe damage may occur.Do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter.Recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water 12 fr.(5cc balloon): use 5.5cc sterile water 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities.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® LUBRI-SIL® I.C. ALL-SILICONE TEMP 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: 20796730
• Report Number: 1018233-2024-07609
• Device Sequence Number: 7894467
• Product Code: MJC
• UDI-Device Identifier: 00801741039928
• UDI-Public: (01)00801741039928
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 119318M
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 12/13/2024; 01/24/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/07/2025; 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Other
• Patient Sex: Unknown