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

Catalog Number	0102L16
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/27/2025
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 patient pulled foley catheter out and only half came out, has a surgery scheduled to remove the other half of the device.Patient had device in for 20 days when they removed it, patient has dementia.It was noted that the given lot#ngjx0928.
Additional Manufacturer Narrative
The reported event was inconclusive because the investigation did not result in any additional findings and no sample was available for evaluation.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: 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.
Event or Problem Description
It was reported that patient pulled foley catheter out and only half came out, has a surgery scheduled to remove the other half of the device.Patient had device in for 20 days when they removed it, patient has dementia.It was noted that the given lot#ngjx0928.Per additional information received via mail on 26aug2025, it was reported that the product was sent to the hospital.It had to be surgically removed by cystoscopy.
Event or Problem Description
It was reported that patient pulled foley catheter out and only half came out, has a surgery scheduled to remove the other half of the device.Patient had device in for 20 days when they removed it, patient has dementia.It was noted that the given lot#ngjx0928.Per additional information received via mail on 26aug2025, it was reported that the patient was sent to the hospital.It had to be surgically removed by cystoscopy.
Additional Manufacturer Narrative
The reported event was inconclusive because the investigation did not result in any additional findings and no sample was available for evaluation.A potential root cause for this failure mode could be, ¿operator error or machine malfunction".The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.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® FOLEY CATHETER TIEMANN MODEL COUDE
• 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 ; 7707846100
• MDR Report Key: 22672147
• Report Number: 1018233-2025-06323
• Device Sequence Number: 3824920
• Product Code: EZC
• UDI-Device Identifier: 00801741018121
• UDI-Public: (01)00801741018121(11)241101(17)280831(10)NGJX0928
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 11/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0102L16
• Device Lot Number: NGJX0928
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 11/10/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/30/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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: Required Intervention
• Patient Sex: Unknown