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

Catalog Number	A800361
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	09/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a sterile water product about to be used for a foley catheter and it was found to be contaminated.Per additional information via email on 14jan2025, it was reported that the category of contamination was unknown.A staff member noticed a foreign substance floating in the sterile water fluid.This occurred on 22sep2024.They unfortunately did not have the faulty product, therefore, no physical sample is available.There was no patient involvement, this was fortunately caught before administration to the patient.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.No actions can be taken at this time since a root cause was not identified.Visual evaluation of the returned photo sample noted one opened (with original packaging), foley tray component sterile water (syringe).Visual inspection of the photo sample noted foreign material inside the sterile water syringe.This does not meet specification which states loose 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: patient has acute urinary retention or bladder outlet obstruction need for accurate urine output measurements in critically ill patients use for selected surgical procedures to assist in healing of open sacral or perineal wounds patient requires prolonged immobilization to improve comfort for end of life care 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.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 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 there was a sterile water product about to be used for a foley catheter and it was found to be contaminated.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY
• 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 30014 ; 7707846100
• MDR Report Key: 21011078
• Report Number: 1018233-2024-08228
• Device Sequence Number: 21077213
• Product Code: EZC
• UDI-Device Identifier: 00801741073939
• UDI-Public: (01)00801741073939(11)240626(17)250731(10)NGJS2711
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2025

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 Expiration Date: 07/31/2025
• Device Catalogue Number: A800361
• Device Lot Number: NGJS2711
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 12/24/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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