MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 SURESTEP INTERMITTENT CATHETER TRAY

Catalog Number	INTL15
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	12/19/2025
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.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 overnight nurse found what looked like mold on one of the castel wipes in an intermittent catheter kit.The kit was not expired.Was caught before being used on patients.
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 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 overnight nurse found what looked like mold on one of the castel wipes in an intermittent catheter kit.The kit was not expired.Was caught before being used on patients.
Additional Manufacturer Narrative
The reported event was confirmed - supplier related.One photo was received for evaluation showing that the cliniclean castel wipes had black marks on them.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.Dhr is unable to be performed as the lot number is unknown.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 overnight nurse found what looked like mold on one of the castel wipes in an intermittent catheter kit.The kit was not expired.Was caught before being used on patients.

• Brand Name: SURESTEP INTERMITTENT CATHETER TRAY
• Common Device Name: INTERMITTENT CATHETER 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: 23915500
• Report Number: 1018233-2025-11487
• Device Sequence Number: 10025300
• Product Code: KOD
• UDI-Device Identifier: 00801741183171
• UDI-Public: (01)00801741183171
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K251864
• 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: Notification,Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

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: INTL15
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: Not provided; 05/11/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/07/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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