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

Catalog Number	129416M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
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.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 there were two patients on the 5th floor and one in trauma intensive care unit that had been found with ruptured balloons on their temperature sensing foley catheters.Per additional information received via email on 02jun2025, it was reported that the patient receiving gentamycin irrigations 2 x daily with 1 hour dwell time.Per reporting nurse stated that the patient complained of sudden, sharp pain at foley insertion site.After assessment, reporting nurse found foley next to patient with balloon not intact.(patient 1).It was reported that the patient was receiving gentamycin irrigations 2 x daily with 1 hour dwell time.Upon reporting nurse evaluation, it was noted that the patient foley was dislodged.After further investigation, it was determined that the balloon had ruptured.(patient 2).No medical intervention provided.
Event or Problem Description
It was reported that there were two patients on the 5th floor and one in trauma intensive care unit that had been found with ruptured balloons on their temperature sensing foley catheters.Per additional information received via email on 02jun2025, it was reported that the patient receiving gentamycin irrigations 2 x daily with 1 hour dwell time.Per reporting nurse stated that the patient complained of sudden, sharp pain at foley insertion site.After assessment, reporting nurse found foley next to patient with balloon not intact.It was reported that the patient was receiving gentamycin irrigations 2 x daily with 1 hour dwell time.Upon reporting nurse evaluation, it was noted that the patient foley was dislodged.After further investigation, it was determined that the balloon had ruptured.No medical intervention provided.
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 could not be performed since no lot number was provided.The instructions for use were found adequate and state the following: warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe stick in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.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.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 5cc balloon: use 10ml sterile water do not exceed recommended capacities.Correction: e 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.

• Brand Name: BARDEX® I.C. 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 30014 ; 7707846100
• MDR Report Key: 22284690
• Report Number: 1018233-2025-04732
• Device Sequence Number: 8921990
• Product Code: MJC
• UDI-Device Identifier: 00801741039775
• UDI-Public: (01)00801741039775
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 129416M
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 90 KG