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

Catalog Number	A947316
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	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.No actions can be taken at this time since a root cause was not identified.Visual evaluation of the two-photo returned sample noted one opened (with original packaging), surestep foley tray.Visual inspection of the first photo sample noted that there was an employee badge laying on top of the csr wrap inside the surestep foley tray kit.The second photo sample noted that the employee badge next to the inside product information laying on top of the csr wrap inside the surestep foley tray kit.This does not meet specification which states product shall be free from visible loose or embedded foreign matter.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: intended for use in the drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterille.These components are not terminally sterilized, warning: do not use if allergic to iodine.For urollogicall use only.Warning: on catheter, do not use ointments or lubricants having a petrollatum base.They will damage silicone and may cause balloon to burst.Correction: b, 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.
Event or Problem Description
It was reported that upon opening a bd surestep foley tray (cat #a947316) in an or suite, the rn discovered a bd employee's badge from nogales, mx plant inside the sterile tray.Attached pictures for reference.This is a serious breach of sterilization protocol and raises concerns about the integrity of your manufacturing process.Per additional information received via email on 20aug2025.It was reported that unfortunately, the physical product was not saved by the rn in the room.However, they did manage to take two pictures of the product showing the badge and product information.Attached images for your reference.The defect was noticed before the product was used on the patient.No patients were harmed.No additional information was provided by the rn or surgical services management at this time.Follow-ups complete.Customer email response is located within the attached files.
Event or Problem Description
It was reported that upon opening a bd surestep foley tray (cat #a947316) in an or suite, the rn discovered a bd employee's badge from nogales, mx plant inside the sterile tray.This is a serious breach of sterilization protocol and raises concerns about the integrity of your manufacturing process.
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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER
• 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: 22787726
• Report Number: 1018233-2025-06710
• Device Sequence Number: 8127817
• Product Code: EZL
• UDI-Device Identifier: 00801741074141
• UDI-Public: (01)00801741074141(11)250604(17)270930(10)NGKS0081
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 09/16/2025

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: Health Professional
• Device Catalogue Number: A947316
• Device Lot Number: NGKS0081
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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