MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER 5CC BALLOON; TEMPERATURE-SENSING FOLEY CATHETER

Catalog Number	129416M
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
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.All available udi information is being provided.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 was inserted into the patient without resistance or difficulty.Urine was visualized in the tubing, and the balloon was inflated with 10 ml of saline.The catheter easily slipped out of the patient's urethra.When assessing the foley, it was noted there was a small hole at the very tip of the catheter where the foley balloon was located.New foley was inserted without additional issues.
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.Dfmea (b)(4) revision 17 was reviewed for this investigation.The reported event is addressed in step 161.This occurrence does not introduce a new hazard or harm.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures.(b)(4) revision 1 was reviewed for this investigation.The reported event is addressed within the labeling as it states" visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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.Correction: d.
Event or Problem Description
It was reported that the foley catheter was inserted into the patient without resistance or difficulty.Urine was visualized in the tubing, and the balloon was inflated with 10ml of saline.The catheter easily slipped out of the patient's urethra.When assessing the foley, it was noted there was a small hole at the very tip of the catheter where the foley balloon was located.New foley was inserted without additional issues.
Additional Manufacturer Narrative
This supplemental mdr is to capture additional information from a follow up, but it does not impact the investigation findings previously submitted.The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.Dfmea ra0301899 revision 17 was reviewed for this investigation.The reported event is addressed in step 161.This occurrence does not introduce a new hazard or harm.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures.Baw7646068 revision 1 was reviewed for this investigation.The reported event is addressed within the labeling as it states, visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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 was inserted into the patient without resistance or difficulty.Urine was visualized in the tubing, and the balloon was inflated with 10ml of saline.The catheter easily slipped out of the patient's urethra.When assessing the foley, it was noted there was a small hole at the very tip of the catheter where the foley balloon was located.New foley was inserted without additional issues.Per follow up information received on 03jan2026, the foley had to be replaced.Physical samples are not available.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER 5CC BALLOON
• Common Device Name: TEMPERATURE-SENSING 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: 23544702
• Report Number: 1018233-2025-10253
• Device Sequence Number: 9448996
• Product Code: MJC
• UDI-Device Identifier: 00801741039775
• UDI-Public: (01)00801741039775(11)250710(17)271031(10)NGKT0829
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2026

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: 129416M
• Device Lot Number: NGKT0829
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 02/03/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/12/2026; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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: 16 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic