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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive ¿ poor sample.It was unknown whether the product had caused the reported failure.Based on the attached video, observed the catheter balloon was deflated.However, the reported event could not be confirmed due to poor sample condition.Unable to identify and confirmed the condition of catheter balloon.Further functional testing could not be performed if only based on the attached video.A potential root cause for this failure mode could be low latex viscosity, short latex dwell time, latex dip speed out too slow causing thin sac.The dhr review could not be performed without a lot number.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.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 when the medical staff intubated the patient, they first tried to inflate the foley catheter balloon.After inflation, the balloon slowly deflated which indicated that the catheter had air leakage and balloon burst.The medical staff then replaced the catheter and successfully intubated the patient after testing it.Hospital department use feedback recently catheter balloon rupture frequently.2024 happened once was inserted tubing after filling saline when the storm bag has video records, mainly concentrated in the 123416c and 18c these two models, the hospital department has been used for many years, there was no problem in the insertion of the tube operation technology, the problem was still in the quality of products as well as the product factory inspection and acceptance.And there was a delay in surgery.Material#123416c and material#123418c.
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.
Event or Problem Description
It was reported that when the medical staff intubated the patient, they first tried to inflate the foley catheter balloon.After inflation, the balloon slowly deflated which indicated that the catheter had air leakage and balloon burst.The medical staff then replaced the catheter and successfully intubated the patient after testing it.Hospital department use feedback recently catheter balloon rupture frequently.2024 happened once was inserted tubing after filling saline when the storm bag has video records, mainly concentrated in the 123416c and 18c these two models, the hospital department has been used for many years, there was no problem in the insertion of the tube operation technology, the problem was still in the quality of products as well as the product factory inspection and acceptance.And there was a delay in surgery.Material#123416c and material#123418c.

• 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: 22236632
• Report Number: 1018233-2025-04697
• Device Sequence Number: 9098370
• Product Code: KOD
• UDI-Device Identifier: 00801741019203
• UDI-Public: (01)00801741019203
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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 Sex: Unknown