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

Catalog Number	7730014L
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	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, after opening, foreign matter found in the foley tray as it was not sealed in a small bag.
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: 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.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.Based on attached photo, it was observed that there was loose brown dirt on the package.Unable to confirm the condition and the origin of the foreign material due to only photo provided for investigation.No functional testing could be performed as only photo sample are provided.Thus, the exact cause on how and when problem occurred could not be determined.A potential root cause for this failure could be ¿defect contributed by vendor/operator error¿ or "improper handling" or "unclean machine/working area".A review of the device labeling have been conducted for investigation purposed.The ifu is attached on the investigation overview element.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.Corrections made to tab(s) f and h.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, foreign matter found in the foley tray as it was not sealed in a small bag.Per follow up information received on 31oct2025, stated that, the foreign matter was inside when the package was opened.

• Brand Name: BARDEX® I.C. COMPLETE CARE® 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: 23416400
• Report Number: 1018233-2025-09726
• Device Sequence Number: 18709370
• Product Code: MJC
• UDI-Device Identifier: 00801741019913
• UDI-Public: (01)00801741019913(11)250411(17)270628(10)MYKN5436
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K910318
• 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): 05/12/2026

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: 7730014L
• Device Lot Number: MYKN5436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 05/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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