MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® FOLEY TRAY

Catalog Number	900016A
Medical Device Problem Codes	Nonstandard Device (1420); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley tray leaflet was bent, and the size was not visible.
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.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.The complete initial reporter's facility name is (b)(6) hospital, (b)(6).The reported event was confirmed ¿ manufacturing related.The product had caused the reported failure.Based on the evaluation, it was found that the leaflet inside the package was crumpled and folded at the area where the fr size sticker was located.Although the fr sticker was present, it was obscured and not visible to the user due to the condition of the leaflet.No abnormalities or damage were observed on the outer packaging or the package components.A review of the manufacturing process indicates that the process can produce this type of defect.Therefore, this failure mode confirmed as manufacturing related.A potential root cause for this failure could be due to operator error (rough handling), user related (rough handling).A review of the device labelling has been conducted for investigation purposed.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, e, f, 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 the foley tray leaflet was bent, and the size was not visible.

• Brand Name: BARDEX® I.C. COMPLETE CARE® 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: 22921719
• Report Number: 1018233-2025-07228
• Device Sequence Number: 10223149
• Product Code: MJC
• UDI-Device Identifier: 00801741019371
• UDI-Public: (01)00801741019371(11)250429(17)280729(10)MYKN7092
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K040658
• 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): 10/17/2025

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 Catalogue Number: 900016A
• Device Lot Number: MYKN7092
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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