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

Catalog Number	0165SI20
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient stated he received a defective foley catheter.He did not have the lot nor serial number.It is unclear if troubleshooting was performed.No medical intervention or patient impact reported.No additional information provided.Per additional information received via email on 05dec2025, patient stated they were unable to get urine to flow through the catheter.He waited a few minutes before trying another catheter.Upon trying a new catheter, urine began to flow.He stated he did not have time to try figuring out what exactly was wrong with it and discarded the packaging with the lot number.A replacement catheter has already been shipped.It is unclear if the lot number was requested.No medical intervention or patient impact reported.No additional information provided.
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.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.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 mode could be due blocked drainage lumen/drainage eye occlusion.The labeling and instructions for use were found to be adequate.The dhr review could not be performed without a lot number.Therefore, no additional action required at this time.Corrections: f, h.Udi format updated with available product information per gudid.H11: sections 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 the patient stated he received a defective foley catheter.He did not have the lot nor serial number.It is unclear if troubleshooting was performed.No medical intervention or patient impact reported.No additional information provided.Per additional information received via email on 05dec2025, patient stated they were unable to get urine to flow through the catheter.He waited a few minutes before trying another catheter.Upon trying a new catheter, urine began to flow.He stated he did not have time to try figuring out what exactly was wrong with it and discarded the packaging with the lot number.A replacement catheter has already been shipped.It is unclear if the lot number was requested.No medical intervention or patient impact reported.No additional information provided.

• Brand Name: BARDEX® I.C. 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, GA 30014 ; 7707846100
• MDR Report Key: 24063197
• Report Number: 1018233-2026-00111
• Device Sequence Number: 9113285
• Product Code: MJC
• UDI-Device Identifier: 00801741016776
• UDI-Public: (01)00801741016776
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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
• Device Catalogue Number: 0165SI20
• 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: 01/03/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/20/2026
• 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