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

Catalog Number	0167V16S
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was admitted to the hospital with symptoms of coughing, phlegm production, chest tightness, and shortness of breath for three months, worsening over the past four days.Diagnosis was done and found that there was pulmonary infection and acute gastritis.Following the doctor's instructions, a disposable sterile urinary foley catheter was left in place for urinary drainage.At 18:30 on (b)(6) 2025, the nurse inserted a disposable sterile urinary catheter into the patient and injected 15 ml of saline solution.The urinary tube was unobstructed.At 18:52, during a ward round, the disposable sterile urinary catheter came out on its own.Upon inspection, the balloon of the disposable sterile urinary catheter was found to be damaged.After examination, the patient was found to be in a sedated state, and it was ruled out that the patient had pulled it out themself.The patient's urethra was undamaged.After immediate standard disinfection, the disposable sterile urinary catheter was replaced, and catheterization was normal without causing any adverse reactions to the patient.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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 confirmed ¿ cause unknown.Based on the attached photo, it was observed that the balloon was burst.However, the exact cause of how and when the problem occurred could not be determined.No further testing could be conducted due to only photo sample is provided.A potential root cause for this failure could be for this failure mode could be user related (example: contact with sharp object/ exposure to petrolatum based products mechanical failure/operator error).A review of the device history record did not show any problems or condition that would have contributed to the reported issue.The instructions for use were found adequate and state the following: structure & composition: the product includes three series: bardex, bardic and bardia.The composition of each series is as follows: bardex, bardic and bardia bi-lumen series are composed of catheter body, inflation cone interface, balloon and valve.Bardia tri-lumen is composed to tube body, inflation cone interface, deflation cone interface, flush cone interface, balloon and valve.¿the product is with silicone coating.The material of catheter body, inflation conical interface, deflation conical interface, flushing conical interface, balloon is natural latex.The material of valve is polypropylene.Sterilized by gamma radiation.Disposable.Scope of application: foley catheter is intended for use in the drainage of urine from the bladder of children and adults.Precaution: this product contains natural rubber latex which may cause allergic reaction.Sterile unless package has been opened or damage.Warning: do not use petroleum substrate lubricants with the latex- based urethral catheters such as petroleum jelly and label liquid paraffin, which will damage latex and may burst balloon.Water-soluble lubricant can be used.Valve type: use luer slip syringe.Do not use needle.To deflate catheter balloon: gentle insert a syringe in the catheter valve.Never use excessive force to make the syringe ¿stick¿ in the valve.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.If permitted by hospital practical, the valve may be cut off.If this fails, please contact an adequately trained professional for assistance, as directed by hospital practical.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Storage: catheters need to be stored at room temperature and keep away from the direct light and preferably stored in the original packing box.Do not use the product of have latex allergy.Correction: d, h.This report references a us equivalent device.The us udi equivalent for this product number is used.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 patient was admitted to the hospital with symptoms of coughing, phlegm production, chest tightness, and shortness of breath for three months, worsening over the past four days.Diagnosis was done and found that there was pulmonary infection and acute gastritis.Following the doctor's instructions, a disposable sterile urinary foley catheter was left in place for urinary drainage.At 18:30 on (b)(6) 2025, the nurse inserted a disposable sterile urinary catheter into the patient and injected 15 ml of saline solution.The urinary tube was unobstructed.At 18:52, during a ward round, the disposable sterile urinary catheter came out on its own.Upon inspection, the balloon of the disposable sterile urinary catheter was found to be damaged.After examination, the patient was found to be in a sedated state, and it was ruled out that the patient had pulled it out themself.The patient's urethra was undamaged.After immediate standard disinfection, the disposable sterile urinary catheter was replaced, and catheterization was normal without causing any adverse reactions to the patient.

• Brand Name: BARDEX® FOLEY CATHETER SILICONE COATED
• 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: 22328907
• Report Number: 1018233-2025-05057
• Device Sequence Number: 9436642
• Product Code: KOD
• UDI-Device Identifier: 00801741019203
• UDI-Public: (01)00801741019203(11)230727(17)280328(10)MYHS1307
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/29/2025

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: 0167V16S
• Device Lot Number: MYHS1307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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 Sex: Unknown