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

Catalog Number	0166L14
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/11/2025
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 the client heard and felt a pop in their abdomen, which was painful.Client came to clinic for assessment urinary catheter had migrated partially out of penis, on removal of catheter there was no normal saline in deflate and when catheter removed the balloon was not intact had tear in it.No medical intervention was reported.
Event or Problem Description
It was reported that the client heard and felt a pop in their abdomen, which was painful.Client came to clinic for assessment urinary catheter had migrated partially out of penis, on removal of catheter there was no normal saline in deflate and when catheter removed the balloon was not intact had tear in it.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure mode could be user related (example: contact with sharp object)/mechanical failure/operator error/thin rubberize layer).Pfmea ra87p003, rev 23 (sac manufacturing process) was reviewed for this investigation.The reported event is addressed in step/item #3.A potential root cause for this failure mode could be low latex viscosity, short latex dwell time, latex dip speed out too slow causing thin sac.Based on information in the pfmea, the risk of this failure is medium.Current controls in place are adequate to mitigate this failure mode.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.The dhr review could not be performed without a lot number.Therefore, no additional action required at this time.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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: LUBRICATH 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 ; 7707846100
• MDR Report Key: 22588084
• Report Number: 1018233-2025-06095
• Device Sequence Number: 9392834
• Product Code: KOD
• UDI-Device Identifier: 00801741017575
• UDI-Public: (01)00801741017575
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: 0166L14
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 07/28/2025
• 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: Male