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

Catalog Number	165816
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/02/2026
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 physicians have recently encountered difficulty removing bard foley catheters in two separate patients (patient 1 & patient 2-row2).In both cases, the balloon did deflate.However, it appeared to leave a residual rim or cuff that made catheter removal challenging.Given that this has now occurred more than once, we would like to speak directly with someone who has detailed knowledge of the product¿s design and balloon mechanics to better understand whether this is a known issue and how to prevent it.They are hoping to connect with someone beyond a general representative ideally a clinical or product specialist who can address this specific concern.Per follow up information received via email on 20mar2026, on (b)(6) 2026, patient 1 presented for suprapubic tube (spt) exchange with a foley catheter, as had been previously performed in office.Despite balloon deflation and application of appropriate traction, the catheter could not be removed.The patient was subsequently taken to the operating room the following day.At that time, the balloon was again deflated and the catheter was removed, with visualization of a residual cuff of balloon material despite full deflation.For patient 1, emergent or for foley catheter exchange.On (b)(6) 2026, patient 2 had a 10 fr bard silicone foley catheter in place for 2 days.Following balloon deflation, the catheter could not be easily removed by nursing staff and required significant traction.Resistance was encountered at the meatus, and a residual cuff of balloon material was again visualized despite full deflation.No physical samples available.They attempted troubleshooting, multiple attempts to deflate balloon slowly and reasonable traction with plenty of lubrication.
Event or Problem Description
It was reported that the physicians have recently encountered difficulty removing bard foley catheters in two separate patients.In both cases, the balloon did deflate.However, it appeared to leave a residual rim or cuff that made catheter removal challenging.Given that this has now occurred more than once, we would like to speak directly with someone who has detailed knowledge of the product¿s design and balloon mechanics to better understand whether this is a known issue and how to prevent it.They are hoping to connect with someone beyond a general representative ideally a clinical or product specialist who can address this specific concern.Per follow up information received via email on 20mar2026, on (b)(6) 2026, patient 1 presented for suprapubic tube (spt) exchange with a foley catheter, as had been previously performed in office.Despite balloon deflation and application of appropriate traction, the catheter could not be removed.The patient was subsequently taken to the operating room the following day.At that time, the balloon was again deflated and the catheter was removed, with visualization of a residual cuff of balloon material despite full deflation.For patient 1, emergent or for foley catheter exchange.On (b)(6) 2026, patient 2 had a 10 fr bard silicone foley catheter in place for 2 days.Following balloon deflation, the catheter could not be easily removed by nursing staff and required significant traction.Resistance was encountered at the meatus, and a residual cuff of balloon material was again visualized despite full deflation.No physical samples available.They attempted troubleshooting, multiple attempts to deflate balloon slowly and reasonable traction with plenty of lubrication.
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.A labeling review could not be performed since no material number was provided.The dhr review could not be performed without a lot number.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: SILICONE 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, GA 30014 ; 7707846100
• MDR Report Key: 24715465
• Report Number: 1018233-2026-02066
• Device Sequence Number: 5726963
• Product Code: EZL
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 165816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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 Age: 15 YR
• Patient Sex: Female
• Patient Weight: 127 LB
• Patient Race: Black Or African American