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

Catalog Number	2551H24
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the critical care nurses reported in an online survey that the patient experienced adverse events (haematuria, blockage) associated with the device 2551h24 bard hydrogel coated prostatic catheter, 3-way straight tip, 30/50ml, 24 fr.The respondent indicated the patient had haematuria as well prior to device placement.No medical or surgical intervention was indicated for the haematuria, however the respondent stated when they had block non-foley catheter, they irrigate with normal saline, and they check for kink and twisting.If did not affect, they have to replace catheter with new one when asked about medical or surgical intervention when related to the blockage.Additionally, the respondent indicated the patient had septicaemia/urosepsis/wound infection prior to device placement and after device placement.When respondent was asked if they believed this complication to be device related after placement, they stated they thought did not use sterile technique completely.Additionally, the respondent indicated the patient experienced false passage creation as a result of the device.When asked if this required medical or surgical intervention the respondent stated when they understand and confirm this complication.They immediately stop insertion and removed a catheter and they have to replace in suprapubic location placement, and they would get antibiotic for prevent more complications and need to do repair surgery.
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.
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 review is not required as the lot number is unknown.The instructions for use were found adequate and states the following: warnings: on catheter, do not use ointments or lubricants having a petroleum base.They will damage catheter and may cause balloon to burst.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness, or death of the patient.Users and or patients within the european union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the member state in which the user and/or patient is established.Users outside of the european union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established.Precautions: do not use device if package is opened or damaged.Do not aspirate urine through drainage funnel wall.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Storage: keep away from sunlight.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 the critical care nurses reported in an online survey that the patient experienced adverse events (haematuria, blockage) associated with the device 2551h24 bard hydrogel coated prostatic catheter, 3-way straight tip, 30/50ml, 24 fr.The respondent indicated the patient had haematuria as well prior to device placement.No medical or surgical intervention was indicated for the haematuria, however the respondent stated when they had block non-foley catheter, they irrigate with normal saline, and they check for kink and twisting.If did not affect, they have to replace catheter with new one when asked about medical or surgical intervention when related to the blockage.Additionally, the respondent indicated the patient had septicaemia/urosepsis/wound infection prior to device placement and after device placement.When respondent was asked if they believed this complication to be device related after placement, they stated they thought did not use sterile technique completely.Additionally, the respondent indicated the patient experienced false passage creation as a result of the device.When asked if this required medical or surgical intervention the respondent stated when they understand and confirm this complication.They immediately stop insertion and removed a catheter and they have to replace in suprapubic location placement, and they would get antibiotic for prevent more complications and need to do repair surgery.

• Brand Name: BARDEX® LUBRICATH® HEMATURIA FOLEY CATHETER
• Common Device Name: HEMATURIA FOLEY CATHETER
• 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 30014 ; 7707846100
• MDR Report Key: 22027324
• Report Number: 1018233-2025-03564
• Device Sequence Number: 9114713
• Product Code: KOD
• UDI-Device Identifier: 00801741025167
• UDI-Public: (01)00801741025167
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2551H24
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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: Required Intervention
• Patient Sex: Unknown