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

Model Number	123512A
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that no urine could be drained out to the urine bag by using the mentioned foley catheter.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all of 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 no urine could be drained out to the urine bag by using the mentioned foley catheter(date of event - (b)(6) 2022) per additional information received on 08aug2022, they were 2 more cases using the same lot having the same problem which was found to be blocked after having used on patient (date of event - (b)(6) 2022 and date of event - (b)(6) 2022).The event occurred in three different patients.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The product had caused the reported failure.Water was introduced into inflation lumen and no blockage or obstruction was observed.Catheter can be inflated without difficulties.However, there are no water flow out from the catheter when drainage lumen was introduced with water.A potential root cause for this failure mode could be "incorrect air pressure setting or incorrect air blow direction setting causing blocked or occluded drainage lumen".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.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: sterile unless package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst.Do not aspirate urine through the drainage funnel wall.Single patient use only.Do not reuse and resterilize.For urological use only.Use luer slip syringe.Do not use needle.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required 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 protocol, the may be cut off.If this fails, contact an 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.The actual/suspected device was inspected.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15225635
• Report Number: 1018233-2022-06384
• Device Sequence Number: 6013754
• Product Code: EZC
• UDI-Device Identifier: 00801741095078
• UDI-Public: (01)00801741095078
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 01/28/2025
• Device Model Number: 123512A
• Device Catalogue Number: 123512A
• Device Lot Number: MYEP2467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2020
• 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