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

Model Number	777428
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter balloon did not come out after being gently pulled after being filled with 10ml of water.The catheter came out on its own the next day, and an inspection revealed that the airbag had broken.Also stated that the nurse replaced the foley catheter.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/operator error).The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿structure & composition: the product include 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 ¿ 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 later allergy.¿ the device was not returned.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12760221
• Report Number: 1018233-2021-06975
• Device Sequence Number: 14867575
• Product Code: KOD
• UDI-Device Identifier: 10801741014496
• UDI-Public: (01)10801741014496
• 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
• Report Date (Section B): 10/18/2021

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 Model Number: 777428
• Device Catalogue Number: 123618A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Sex: Female