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

Catalog Number	0165SI22
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
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 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.
Event or Problem Description
It was reported that the foley catheter had rust on it (pcn d236522s).The photos of the second catheter were found to be damaged (pcn z01).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.For (pcn d236522s) and another (pcn z01).
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (with original packaging), used silicone foley (d236522s) with batch number (nghx3889).Visual inspection of the sample noted the catheter was inspected and it was confirmed that there was foreign material within the eyelet.This does not meet specification which states "the product/assembly must be free of visible, lose or etched foreign matter, solvent spills, hair, etc".The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: d, e, f, h.This report references a us equivalent device.The us udi equivalent for this product number is used.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.

• 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: 22053414
• Report Number: 1018233-2025-03680
• Device Sequence Number: 5228822
• Product Code: MJC
• UDI-Device Identifier: 00801741016783
• UDI-Public: (01)00801741016783(11)231130(17)251031(10)NGHX3889
• Combination Product (Y/N): N
• 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): 02/06/2026

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 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: 05/19/2025
• 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: 02/06/2026
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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