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	03/01/2021
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.The device was not returned.
Event or Problem Description
It was reported that the urinary tube was found to slip off the next morning, and the foley catheter balloon was broken which was inserted into the patient on (b)(6) 2021.Also stated that the balloon was inflated and checked before the operation, and 15ml of normal saline was injected.
Event or Problem Description
It was reported that the urinary tube was found to slip off the next morning, and the foley catheter balloon was broken, which was inserted into the patient on (b)(6) 2021.It was also stated that the balloon was inflated and checked before the operation, and 15ml of normal saline was injected.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A 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 device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "sterilization method: sterile, sterilized by g radiation.Do not use if package is opened or damaged.Disposable.Destroy after use.Do not use this product if you have a latex allergy.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, deflation cone interface, balloon and valve.Bardia tri-lumen series is composed of tube body, inflation cone interface, deflation cone interface, flush cone interface, balloon and valve.Material of components: catheter body ¿ natural latex, inflation conical interface ¿ natural latex, deflation conical interface ¿ natural latex, flushing conical interface ¿ natural latex, balloon ¿ natural latex, valve ¿ polypropylene.Scope of application: foley catheter is intended for use in the drainage of urine from the bladder of children and adults.Precautions: this product contains natural rubber latex which may cause allergic reaction.Sterile unless package has been opened or damaged.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.Do not aspirate urine through the drainage funnel wall.Single use only.Do not re-sterilize.For urological use only.Please inspect visually for completeness or surface wear of the product before it is used.Valve type: use luer slip syringe.Do not use needle.To deflate catheter balloon: gently 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 direct light, preferably stored in the original packing box.Precautions: federal (usa) law restricts this device to sale by or on the order of a physician." 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: 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: 12746682
• Report Number: 1018233-2021-06919
• Device Sequence Number: 12440812
• 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,Followup
• Report Date (Section B): 11/18/2021

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 Expiration Date: 03/28/2024
• Device Model Number: 777428
• Device Catalogue Number: 123618A
• Device Lot Number: MYDT3100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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: 75 YR
• Patient Sex: Female