MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardex® Lubricath® Foley Catheter; Latex Foley Catheter

Catalog Number	0166L16
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use a difference was perceived in the packaging and thickness regarding the bd foley catheter with reference (b)(4).The user indicated that, despite the same reference, a difference was experienced in the packaging for lot mykq3362 for lot myjn5697 and thickness of the catheter for lot mykq3362 and lot myjn5697.Since delivery of the "new" variant, the customer had experienced discomfort while wearing it.Per follow up information received via rcc on 24apr2026, stated that the customer has not been harmed by the issue that prompted the complaint.The customer simply noticed it and is wondering if something has changed.
Additional Manufacturer Narrative
The initial reporter's phone number: (b)(6).The initial reporter's fax number: (b)(6).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.

• Brand Name: Bardex® Lubricath® Foley Catheter
• Common Device Name: Latex Foley Catheter
• 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 ; +1(770)784-6100
• MDR Report Key: 25106773
• Report Number: 1018233-2026-03005
• Device Sequence Number: 21181346
• Product Code: KOD
• UDI-Device Identifier: 00801741017582
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 0166L16
• Device Lot Number: MYJN5697
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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