MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY

Catalog Number	A897518
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Hematuria (2558)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
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: 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 clinician was changing out the gloves from the kit and the patient was excreting blood in urine.When the foley was changed out and the registered nurse removed the gloves there was the presence of the blood and urine on their hands.They checked to see if there were any tears or holes but could not find anything.Registered nurse did not require any diagnostic testing.They just washed their hands, and the material management also stated that there have been other events which had occurred similar to this event within the facility and the gloves have been pulled until further review.It was unknown what medical intervention was provided.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted three opened (with original packaging), sure step foley tray system.Received three unopened trays material number a897518 and batch number nghy3407(qty.1), batch number ngju0735(qty.2).Visual inspection of the sample noted the three pairs of gloves were visually inspected and filled up with water to verify any cuts/holes and no defects were noted.No root cause could be found because the reported event was unconfirmed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.As the reported event is unconfirmed a labeling review is not required.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 clinician was changing out the gloves from the kit and the patient was excreting blood in urine.When the foley was changed out and the registered nurse removed the gloves there was the presence of the blood and urine on their hands.They checked to see if there were any tears or holes but could not find anything.Registered nurse did not require any diagnostic testing.They just washed their hands, and the material management also stated that there have been other events which had occurred similar to this event within the facility and the gloves have been pulled until further review.It was unknown what medical intervention was provided.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE 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: 21112804
• Report Number: 1018233-2024-08692
• Device Sequence Number: 8733209
• Product Code: EZL
• UDI-Device Identifier: 00801741073991
• UDI-Public: (01)00801741073991(11)240131(17)260131(10)NGHY3407
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: A897518
• Device Lot Number: NGHY3407
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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