MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED

Catalog Number	123522A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Irritability (2421); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/12/2024
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.This report references a us equivalent device.The us udi equivalent for this product number is used.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 irrigation, vesicoureteral reflux, irritation directly caused or attributable to usage of the device bardia silicone elastomer coated latex 2-way, 10ml foley catheter, 22 fr.And resulted in patient injury following this medical or surgical intervention suturing.
Event or Problem Description
It was reported that the critical care nurses reported in an online survey that the patient experienced adverse events irrigation, vesicoureteral reflux, irritation directly caused or attributable to usage of the device bardia silicone elastomer coated latex 2-way, 10ml foley catheter, 22 fr.And resulted in patient injury following this medical or surgical intervention suturing.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be operator error/mechanical failure causing improper leaching.A potential root cause for this failure mode could be allergic reaction in patient.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: warning: do not use ointments or lubricants having a petroleum base.They will damage the latex.Visually inspected the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with state 10ml of sterile water or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.For urological use only.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.Allow the pressure within to balloon 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 necessary, contact adequately trained professional for assistance, as directed by hospital protocol.This report references a us equivalent device.The us udi equivalent for this product number is used.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: BARDIA® FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 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: 21047209
• Report Number: 1018233-2024-08433
• Device Sequence Number: 19685337
• Product Code: EZC
• UDI-Device Identifier: 00801741095122
• UDI-Public: (01)00801741095122
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K910846
• 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): 01/08/2025

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: 123522A
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/22/2025
• 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
• Patient Sex: Unknown