MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER

Catalog Number	A947316
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during foley lifecycle assessment, the foley tray that the nurse pulled from their supply room did not have iodine.
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.
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.No additional actions can be taken at this time since root cause was not identified.The dhr review could not be performed without a lot number.A labeling review was not performed because labeling could not have prevented the reported failure.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 during foley lifecycle assessment, the foley tray that the nurse pulled from their supply room did not have iodine.
Event or Problem Description
It was reported that during foley lifecycle assessment, the foley tray that the nurse pulled from their supply room did not have iodine.Per additional information received via email on 03apr2025, this was found during a foley point prevalence review with bd.The kit was to be used on a model, not a patient.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A labeling review was not performed because labeling could not have prevented the reported failure.Pfmea # (b)(4), revision 37, was reviewed for this investigation.The reported event is addressed in step #3.Based on this review the risk is within the expected range.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction: d, e 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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® 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: 21696649
• Report Number: 1018233-2025-02007
• Device Sequence Number: 9419547
• Product Code: EZL
• UDI-Device Identifier: 00801741074141
• UDI-Public: (01)00801741074141(11)240926(17)260331(10)NGJV2378
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2025

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: Lay User/Patient
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: A947316
• Device Lot Number: NGJV2378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 03/27/2025; 07/16/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/03/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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