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

Catalog Number	A319416AM
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	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the gauze in the foley tray looks to be dirty or looked burnt.
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.
Event or Problem Description
It was reported that one of the gauze in the foley tray looks to be dirty or looked burnt.
Additional Manufacturer Narrative
The reported event was confirmed, supplier related.Received 1 sure step foley tray system.Verified material number a319516am and batch number ngkt2391.Visual inspection noted black substance on the gauze.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.Based on the results of the investigation, no additional actions can be taken at this time.Correction: d 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.
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 ((b)(4)) to investigate root cause of the problem.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, f, 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 one of the gauze in the foley tray looks to be dirty or looked burnt.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER
• Common Device Name: FOLEY TRAY
• 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: 23390516
• Report Number: 1018233-2025-09575
• Device Sequence Number: 18628307
• Product Code: MJC
• UDI-Device Identifier: 00801741073861
• UDI-Public: (01)00801741073861(11)250730(17)271130(10)NGKT2391
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2026

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: A319416AM
• Device Lot Number: NGKT2391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 03/20/2026; 05/05/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 04/14/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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 FIELD ACTIO
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown