MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER

Catalog Number	899616
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
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 just received foley tray.They opened two of the kits of the swabs and there was no iodine on the swabs.They purchased from (b)(6), but they refused to replace, and they had to dispose because the product was no longer sterile.Customer requested replacement of 2 kits tray1 & tray2.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A dhr could not be performed since no lot number was provided.A labeling review is not required because labeling could not have prevented the reported failure.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 just received foley tray.They opened two of the kits of the swabs and there was no iodine on the swabs.They purchased from edge park, but they refused to replace, and they had to dispose because the product was no longer sterile.Customer requested replacement of 2 kits tray1 & tray2.

• Brand Name: BARD® FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER
• 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, GA 30014 ; 7707846100
• MDR Report Key: 20749262
• Report Number: 1018233-2024-07407
• Device Sequence Number: 8372140
• Product Code: EZC
• UDI-Device Identifier: 00801741000287
• UDI-Public: (01)00801741000287
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 899616
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/11/2025
• 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