MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® TEMPERATURE-SENSING URINE METER FOLEY TRAY

Catalog Number	909116M
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	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed ¿ manufacturing related.The product had caused the reported failure.Based on the evaluation, observed there was a foreign material attached at the connection of the sample port.A visual inspection was conducted, revealing that the foreign material originated from the catheter polysleeve.Evidence of tearing was noted on the polysleeve, indicating it as the source of the contamination.This issue is confirmed to be related to the manufacturing process, as the connection area is part of that process.A potential root cause of this failure could be the operator¿s handling method during the assembly of the sample port to the drainage tubing of the drainage bag/umb, which may cause the polysleeve to get caught between the sample port and the drain tube.The labeling and instructions for use were found to be adequate.A review of the manufacturing process indicates that the process is capable of producing of this type of defect.However, current in-process controls per pfmea are adequate to identify the defect or verify the product integrity.Corrections: d, h.This report references a us equivalent device.The us udi equivalent for this product number is used.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.
Event or Problem Description
It was reported that after opening the foley tray product there was a blue plastic stuck at the connection point between the bag and catheter.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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 after opening the foley tray product there was a blue plastic stuck at the connection point between the bag and catheter.

• Brand Name: BARDEX® LUBRICATH® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• 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, GA 30014 ; 7707846100
• MDR Report Key: 23096390
• Report Number: 1018233-2025-08349
• Device Sequence Number: 21168881
• Product Code: EZC
• UDI-Device Identifier: 00801741029158
• UDI-Public: (01)00801741029158(11)250515(17)270628(10)MYKN7041
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 909116M
• Device Lot Number: MYKN7041
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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