MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM COMPLETE CARE® ADD-A-FOLEY CATHETER; FOLEY TRAY ADD-CATHETER

Catalog Number	A304400A
Medical Device Problem Code	Fungus in Device Environment (2316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
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.All available udi information is being provided.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 customer received another complaint for a304400a.Mold was found in the cliniclean castile soap toilettes that came individually packed in the surestep foley tray system without a foley catheter.Ref# a304400a, lot# ngku3043, exp 07-31-2026, toilette lot10) mk05525.It was discarded and never used on the patient.No expiration date was available on the cliniclean package.
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 was not performed because labeling could not have prevented the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d.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 customer received another complaint for a304400a.Mold was found in the cliniclean castile soap toilettes that came individually packed in the surestep foley tray system without a foley catheter.Ref #(b)(4), lot # ngku3043, exp 07-31-2026, toilette lot10) mk05525.It was discarded and never used on the patient.No expiration date was available on the cliniclean package.
Additional Manufacturer Narrative
The reported event was confirmed - supplier related.Visual evaluation of the returned one-photo sample noted one opened (with original packaging), foley tray care kit.Visual inspection of the one photo sample noted foreign black substance on the towelette inside of the foley tray care kit.Reported event was evaluated within sa # (b)(4).Product labeling was reviewed for this investigation.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d,h.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 customer received another complaint for a304400a.Mold was found in the cliniclean castile soap toilettes that came individually packed in the surestep foley tray system without a foley catheter.Ref#a304400a, lot# ngku3043, exp 07-31-2026, toilette lot10) mk05525.It was discarded and never used on the patient.No expiration date was available on the cliniclean package.
Additional Manufacturer Narrative
Ucc-26-06029 field action has been initiated by bd.A customer/distributor advisory letter identifying the issue will instruct to not use and discard the wipes within the trays and source alternate wipes prior to initiating treatment/procedure.A scar has been issued (dm-cc-112025-001) to investigate root cause of the problem.The reported event was confirmed - supplier related.Visual evaluation of the returned one-photo sample noted one opened (with original packaging), foley tray care kit.Visual inspection of the one photo sample noted foreign black substance on the towelette inside of the foley tray care kit.Reported event was evaluated within sa ucc-26-06029.See attachment for investigation details.Product labeling was reviewed for this investigation.The reported event is addressed within the labeling.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.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 customer received another complaint for (b)(4).Mold was found in the cliniclean castile soap toilettes that came individually packed in the surestep foley tray system without a foley catheter.Ref#(b)(4), lot# ngku3043, exp 07-31-2026, toilette lot10) mk05525.It was discarded and never used on the patient.No expiration date was available on the cliniclean package.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM COMPLETE CARE® ADD-A-FOLEY CATHETER
• Common Device Name: FOLEY TRAY ADD-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: 23658436
• Report Number: 1018233-2025-10587
• Device Sequence Number: 10027422
• Product Code: KNX
• UDI-Device Identifier: 00801741073847
• UDI-Public: (01)00801741073847(11)250724(17)260731(10)NGKU3043
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Remedial Action: Other,Recall,Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/06/2026

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: 07/31/2026
• Device Catalogue Number: A304400A
• Device Lot Number: NGKU3043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 02/12/2026; 03/20/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/12/2025; 02/24/2026; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: UCC-26-06029
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown