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

Catalog Number	119416M
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
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 the foley catheter balloon had been deflated with 10cc prior to removal.The writer had attempted to remove the foley catheter at the bedside, but resistance had been encountered at the meatus of penis.The writer notified the charge nurse, and with the charge nurse¿s assistance, attempted to readvance the catheter and remove it again, however, resistance had again been met.The physician assistant was notified, and the foley was left in place.The foley catheter was later removed by the physician assistant with support from the urology service, though this removal was not witnessed by the writer.After removal, the patient had reported 9/10 pain, and a small amount of blood drainage had been noted during assessment.
Event or Problem Description
It was reported that the foley catheter balloon had been deflated with 10 cc prior to removal.The writer had attempted to remove the foley catheter at the bedside, but resistance had been encountered at the meatus of penis.The writer notified the charge nurse, and with the charge nurse¿s assistance, attempted to readvance the catheter and remove it again; however, resistance had again been met.The physician assistant was notified, and the foley was left in place.The foley catheter was later removed by the physician assistant with support from the urology service, though this removal was not witnessed by the writer.After removal, the patient had reported 9/10 pain, and a small amount of blood drainage had been noted during assessment.
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.A dhr could not be performed since no lot number was provided.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 foley catheter balloon had been deflated with 10cc prior to removal.The writer had attempted to remove the foley catheter at the bedside, but resistance had been encountered at the meatus of penis.The writer notified the charge nurse, and with the charge nurse¿s assistance, attempted to readvance the catheter and remove it again; however, resistance had again been met.The physician assistant was notified, and the foley was left in place.The foley catheter was later removed by the physician assistant with support from the urology service, though this removal was not witnessed by the writer.After removal, the patient had reported 9 out of 10 pain, and a small amount of blood drainage had been noted during assessment.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Corrections: b, d, e, f, h udi format updated with available product information per gudid.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® Temperature Sensing 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, GA 30014 ; +1(770)784-6100
• MDR Report Key: 24633254
• Report Number: 1018233-2026-01602
• Device Sequence Number: 21086379
• Product Code: EZC
• UDI-Device Identifier: 00801741046148
• UDI-Public: (01)00801741046148(11)250911(17)300228(10)NGKV3798
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/18/2026

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: 119416M
• Device Lot Number: NGKV3798
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/18/2026
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/17/2026; 05/18/2026; 08/18/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/27/2026; 06/09/2026; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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 Age: 39 YR
• Patient Sex: Male