MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®; SILICONE FOLEY TRAY

Catalog Number	A303416A
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
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 foley tray was damaged, internal leak.
Event or Problem Description
It was reported that foley tray was damaged, internal leak.Per additional information received via email on 16sep2025, it was reported that cath tray - (b)(6) - tray cath 16 fr kit indwell lat free 5 cc ball ¿ was delivered by our vendor.Inventory control staff discovered the tray was damaged (see attached photo).There were no obvious signs of damage to the exterior of the packaging, and the outer poly wrap was still intact.The tray was removed from the vendor¿s delivery tote and isolated against accidental use.Leadership was notified to investigate, and a report was submitted to the vendor.No other actions were taken to determine the cause of the leakage to the tray.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned one-photo sample noted one opened (with original packaging), lubrisil surestep foley trays.Visual inspection of the one-photo sample noted that the povidone iodine solution packet leaked through the tray system.The labeling is found to be adequate.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.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
The reported event was confirmed cause unknown.Visual evaluation of the returned one-photo sample noted one opened (with original packaging), lubrisil surestep foley trays.Visual inspection of the one-photo sample noted that the povidone iodine solution packet leaked through the tray system.The labeling is found to be adequate.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: b, d, e, 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 foley tray was damaged, internal leak.Per additional information received via email on 16sep2025, it was reported that cath tray - abrda 303416a - tray cath 16 fr kit indwell lat free 5 cc ball ¿ was delivered by our vendor.Inventory control staff discovered the tray was damaged.There were no obvious signs of damage to the exterior of the packaging, and the outer poly-wrap was still intact.The tray was removed from the vendor¿s delivery tote and isolated against accidental use.Leadership was notified to investigate and a report was submitted to the vendor.No other actions were taken to determine the cause of the leakage to the tray.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Common Device Name: SILICONE 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: 23073008
• Report Number: 1018233-2025-08217
• Device Sequence Number: 9997134
• Product Code: EZL
• UDI-Device Identifier: 00801741073823
• UDI-Public: (01)00801741073823(11)250711(17)270930(10)NGKT1694
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 03/31/2026

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: A303416A
• Device Lot Number: NGKT1694
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 03/25/2026; 03/31/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 03/30/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown