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

Catalog Number	165818
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Sepsis (2067); Urinary Retention (2119); Dysuria (2684); Kidney Infection (4502); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
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 adverse events directly caused / attributable to the usage of device all-silicone foley catheter, 2-way, standard length, 5cc balloon, 18 fr and resulted in the following complications: balloon rupture, urine retention, catheter encrustation, pyelonephritis, irrigation, hydronephrosis.For all of these complications the respondent indicated the patient required medical or surgical intervention, however when asked to describe the medical or surgical intervention stated none for every complication.Additionally, the nurse stated that the patient experienced the following adverse events but indicated them to be procedure related complications: dysuria without symptomatic urinary tract infection, urethrocutaneous fistula, blockage, bladder spasms, septicemia/urosepsis, vesicoureteral reflux, irritation.It was unknown what medical intervention was provided.
Event or Problem Description
It was reported that the critical care nurses reported in an online survey that the patient experienced adverse events directly caused / attributable to the usage of device all-silicone foley catheter, 2-way, standard length, 5cc balloon, 18 fr and resulted in the following complications: balloon rupture, urine retention, catheter encrustation, pyelonephritis, irrigation, hydronephrosis.For all of these complications the respondent indicated the patient required medical or surgical intervention, however when asked to describe the medical or surgical intervention stated none for every complication.Additionally, the nurse stated that the patient experienced the following adverse events but indicated them to be procedure related complications: dysuria without symptomatic urinary tract infection, urethracutaneous fistula, blockage, bladder spasms, septicemia/urosepsis, vesicoureteral reflux, irritation.It was unknown what medical intervention was provided.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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® ALL-SILICONE FOLEY CATHETER
• Common Device Name: 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: 21344279
• Report Number: 1018233-2025-00741
• Device Sequence Number: 20796936
• Product Code: EZL
• UDI-Device Identifier: 00801741029769
• UDI-Public: (01)00801741029769
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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): 02/21/2025

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: Health Professional
• Device Catalogue Number: 165818
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/24/2025
• 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: Other
• Patient Sex: Unknown