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

Catalog Number	A942216
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
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.Initial reporter phone: (b)(6).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 before use, the nursing staff reported that upon opening the tray, the iodine packet was found to be ruptured, and the solution had leaked throughout the entire tray.This incident has affected the usability of the kit.They found 5 trays with same issues.
Event or Problem Description
It was reported that before use, the nursing staff reported that upon opening the tray, the iodine packet was found to be ruptured, and the solution had leaked throughout the entire tray.This incident has affected the usability of the kit.They found 5 trays with same issues.
Additional Manufacturer Narrative
The reported event was confirmed - manufacturing related.Received 1 sure step foley tray system in unopened packaging and 1 sure step foley tray system in open packaging.Verified material number a942216 and batch number nghx2379.Visual inspection noted the iodine packet was found to be ruptured, and the solution had leaked throughout the entire tray.The labeling was reviewed and found to be adequate.Dhr review did not show any problems or conditions that would have contributed to the reported event.Based on the results of the investigation no additional actions are required 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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY
• Common Device Name: FOLEY 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: 22346389
• Report Number: 1018233-2025-05206
• Device Sequence Number: 20033594
• Product Code: EZL
• UDI-Device Identifier: 00801741074110
• UDI-Public: (01)00801741074110(11)231117(17)260228(10)NGHX2379
• Combination Product (Y/N): Y
• Initial Reporter Country: SA
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 02/28/2026
• Device Catalogue Number: A942216
• Device Lot Number: NGHX2379
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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