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

Catalog Number	226520
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
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.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 one of the foley catheter items had a sticker indicating 5ml instead of 10ml, the one at the top.Additionally, the packaging differs as the top product appeared to be from bd, while the other was from bard.
Additional Manufacturer Narrative
The reported event was unconfirmed as the product meets specifications.Visual evaluation of the submitted one photo sample showed two unopened biocath hydrogel coated foley catheters, both in their original packaging.The top catheter (batch mykn1526) displays a sticker indicating a ¿5 ml balloon¿ but lists a 10 ml inflation volume.The bottom catheter (batch myjv6221) displays a sticker indicating a ¿10 ml balloon¿ but does not list an inflation volume.This meets specifications.As the reported event is unconfirmed, a labeling review is not required.Dhr is not required since the reported failure was unconfirmed.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: b, d, 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 one of the foley catheter items had a sticker indicating 5ml instead of 10ml, the one at the top.Additionally, the packaging differs as the top product appeared to be from bd, while the other was from bard.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: 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 30014 ; 7707846100
• MDR Report Key: 22631171
• Report Number: 1018233-2025-06216
• Device Sequence Number: 9074162
• Product Code: EZC
• UDI-Device Identifier: 00801741017506
• UDI-Public: (01)00801741017506(11)250327(17)291128(10)MYKN1546
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 226520
• Device Lot Number: MYKN1546
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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