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

Catalog Number	0165SI22
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
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 foley catheter had rust on it.The photos of the second catheter were found to be damaged.The packaging was all sealed up before opening first layer, then opening blue cover on catheter.As if mentioned, was second one in a matter of weeks and had thrown out first one but kept this one to send to bard.The flash is turned on so could see the brown stuff along with size of hole.That's clearly bigger, they're stored in the bedroom unit beside my bed.No excessive heat, condensation.The size of hole was first clue, had with first faulty catheter and this one exact same, then turned flash on and saw how gross it actually was.The patient had the two units since january.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (with original packaging), used silicone foley.Visual inspection of the sample noted the catheter was inspected and did not find any evidence of a failure that would support the reported event.Flow rate test was performed on the returned catheter and water able to pass through.No root cause could be found because the reported event was unconfirmed.Dhr is not required since the reported failure was unconfirmed.As the reported event is unconfirmed, a labeling review is not required.Correction- d, h.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 foley catheter had rust on it.The photos of the second catheter were found to be damaged.The packaging was all sealed up before opening first layer, then opening blue cover on catheter.As if mentioned, was second one in a matter of weeks and had thrown out first one but kept this one to send to bard.The flash is turned on so could see the brown stuff along with size of hole.That's clearly bigger, they're stored in the bedroom unit beside my bed.No excessive heat, condensation.The size of hole was first clue, had with first faulty catheter and this one exact same, then turned flash on and saw how gross it actually was.The patient had the two units since january.

• 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: 22054002
• Report Number: 1018233-2025-03681
• Device Sequence Number: 20131870
• Product Code: MJC
• UDI-Device Identifier: 00801741016783
• UDI-Public: (01)00801741016783(11)231130(17)251031(10)NGHX3889
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 0165SI22
• Device Lot Number: NGHX3889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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