MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® FOLEY CATHETER TRAY AND URINE METER; FOLEY TRAY

Catalog Number	303316A
Medical Device Problem Codes	Inadequate or Insufficient Training (1643); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
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 customer said packaging stated latex free, but there was latex in the package.No adverse event or patient impact.Nurses were catching this prior to use.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as they created educational plan for the nurses on the changes.This report is being submitted as additional information.The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.No additional actions can be taken at this time.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: "caution: this product contains natural rubber latex which may cause allergic reactions.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst." correction: d, f, 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 customer said packaging stated latex free, but there was latex in the package.No adverse event or patient impact.Nurses were catching this prior to use.Per additional information received on 01apr2025, it was reported that customer who informed that it was not that the packaging stated latex free, but there was latex in the package but that they were not informed that bd was changing from no latex to using latex in the foley tray.Customer stated that had gotten the biohazard box but was not going to send anything back, the complaint was submitted based on the lack of notification that was provided to the facility prior to the change.Customer informed they had been using the product for years and it was never latex and prior to a procedure it was noticed by the nurse.They had old trays that have a blue dot indicating items were not made with latex.They have created an education plan to inform nurses of the change as this could be a safety concern.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY CATHETER TRAY AND URINE METER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 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: 21688456
• Report Number: 1018233-2025-01987
• Device Sequence Number: 21045212
• Product Code: MJC
• UDI-Device Identifier: 00801741024269
• UDI-Public: (01)00801741024269(11)240906(17)260331(10)NGJU3567
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• 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): 06/17/2025

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: 03/31/2026
• Device Catalogue Number: 303316A
• Device Lot Number: NGJU3567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2024
• 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