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

Catalog Number	73016SI
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Sepsis (2067); Hematuria (2558)
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 and adverse event directly caused attributable to the usage of foley catheter and resulted in hematuria and sepsis.It was unknown what medical intervention was provided for the sepsis and hematuria.
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 by the critical care nurses in an online survey that the patient experienced and adverse event directly caused attributable to the usage of foley catheter and resulted in hematuria and sepsis.It was unknown what medical intervention was provided for the sepsis and hematuria.Per additional information received via mail on 13dec2024, stated that the respondent indicated the patient did require medical or surgical intervention and stated patient might need dialysis and for the sepsis complication experienced they indicated medical or surgical intervention was required and stated surgery when asked to elaborate.
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.No actions can be taken at this time since a root cause was not identified.A dhr could not be performed since no lot number was provided.The instructions for use were found adequate and state the following: bardex lubri-sil i.C.All-silicone foley catheter infection control all-silicone foley catheter (latex free) warning: do not use ointments or ointments on the catheter or lubricants having petrolatum based lubricants.They will damage the silicone and may make the balloon burst.Warning: after use, this product may pose a risk biological potential.Handle and dispose in accordance with laws and applicable local, state and federal regulations.Caution: federal law (us) restricts this device to sale by physicians.Or by optional prescription.Caution: do not aspirate urine through the wall of the drain funnel.Storage: store catheters at room temperature, away from direct exposure to light, preferably in the original box.Note: aggressive traction is not recommended, particularly in the presence of sutures, for 100 percentage silicone foley catheters.Sterile unless the package is opened or damaged.Exclusive use for a single patient.Do not reuse.Do not resterilize.For urological use only.Valve type: use a luer-slip type syringe.Do not use needle.Catheters should be replaced according to the guidelines of the cdc guideline for the prevention of associated urinary tract infections to catheters.At the appearance or first signs of a urinary tract infection, catheter encrustation or any other catheter-related adverse effect, the catheter should be replaced.To deflate the catheter balloon: gently insert a syringe into the catheter valve.Never use more force than necessary to make the syringe stick to the valve.If you notice that the deflation is slow or absent, carefully reinsert the syringe.Let the balloon deflate slowly on its own only.Do not manually vacuum or accelerate balloon deflation.If hospital protocol allows it, can cut the valve arm.If this fails, contact an appropriately trained professional for help, as directed by hospital protocol.Should balloon rupture, care must be taken to ensure that all fragments of the patient's balloon.Visually inspect the product for imperfections or surface deterioration before use.Recommended inflation capacities.5 cc balloon: use 10 cc of sterile water 30cc balloon: use 35cc sterilized water do not exceed recommended capacities.Utis represent the 40 percentage of infections nosocomial.In vitro tests of bacterial adhesion show that lubri- sil i.C.The coating of the foley catheter reduces the accession of the bacteria most commonly associated with infections nosocomial uti.Correction: b,f,h 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 FOLEY CATHETER
• Common Device Name: SILICONE 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, GA 30014 ; 7707846100
• MDR Report Key: 20797796
• Report Number: 1018233-2024-07634
• Device Sequence Number: 7894495
• Product Code: MJC
• UDI-Device Identifier: 00801741025488
• UDI-Public: (01)00801741025488
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 73016SI
• 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: 01/08/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/17/2025
• 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