MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM COMPLETE CARE® ADD-A-FOLEY 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	01/05/2026
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.Complete initial reporter facility name: (b)(6) hospital.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 customer found black mold growing in the prep packet of the foley.This was the second instance this had happened in the or.Product was discarded and new product opened.
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 dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: b,e,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 customer found black mold growing in the prep packet of the foley.This was the second instance this had happened in the or.Product was discarded and new product opened.
Event or Problem Description
It was reported that customer found black mold growing in the prep packet of the foley.This was the second instance this had happened in the or.Product was discarded and new product opened.
Additional Manufacturer Narrative
The reported event was confirmed - supplier related.Photo sample visual evaluation: visual evaluation of the returned three-photo sample noted one opened, foley tray care kit.Visual inspection of the first photo and second sample noted foreign black substance on the towelette inside of the foley tray care kit with (supplier lot no.(b)(4)).The third photo shows the tray catalogue with pcn of tray #a304400a.As per the photo sample reported event is confirmed.A risk review was not performed due to the applicable fmea's were controlled and managed by the quality system of supplier.A labeling review was not performed because labeling could not have prevented the reported failure.A device history record review could not be performed since no lot number was provided.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 customer found black mold growing in the prep packet of the foley.This was the second instance this had happened in the operating room.Product was discarded and new product opened.(doe (b)(6) 2026) and (doe unk).
Additional Manufacturer Narrative
Ucc 26 06029 field action has been initiated by bd.A customer and 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 and procedure.A scar has been issued (dm cc (b)(4)) to investigate root cause of the problem.Initial reporter's facility name: (b)(6).The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Corrections: b, d, e, 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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM COMPLETE CARE® ADD-A-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: 24093579
• Report Number: 1018233-2026-00160
• Device Sequence Number: 10209803
• Product Code: KNX
• UDI-Device Identifier: 00801741073847
• UDI-Public: (01)00801741073847
• 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,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: A304400A
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 03/20/2026; 04/16/2026; 05/05/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/14/2026; 04/15/2026; 04/17/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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