MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Unknown Latex Foley Catheter

Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer had experienced with at least three of our bard council tip catheters.Instead of the balloon inflating at the tip of the catheter within the patient's bladder, it inflated at the fork where the syringe connection and foley bag attachment sites were located.For today¿s issue, the ref# is (b)(4) and the lot# is nglr3780.Customer also had issues where there was a leak at the y junction and the fluid in the balloon port leaked out.They had two patient's council catheters fell out after surgery.
Additional Manufacturer Narrative
Corrections made to tab d.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The reported product number is unknown.The udi number for this product is not available.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: Unknown Latex Foley Catheter
• 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 ; +1(770)784-6100
• MDR Report Key: 50620017
• Report Number: 1018233-2026-05737
• Device Sequence Number: 13436173
• Product Code: EZC
• UDI-Device Identifier: 00801741017926
• UDI-Public: (01)00801741017926(17)280531(10)NGLR3780
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• 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): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/11/2026
• 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 Sex: Unknown