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

Model Number	806522
Medical Device Problem Codes	Failure to Infuse (2340); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had 2 foley catheters that had an issue and it happened on the same patient, so it took them 3 foleys for one patient.The foley catheter was blowing up right below the lurelock, not allowing them to blow up the balloon during a routine foley change.The patient had to have multiple foleys inserted until one worked, and it was not a great experience.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.Although an exact root cause could not be determined a potential root cause could be valve damaged, poor molding, incorrect dimensions.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: "to deflate catheter balloon: gently insert a luer slip tip 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.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact 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.Visually inspect the product for any imperfections or surface deterioration prior to use." correction: d, g, h h11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the customer had 2 foley catheters that had an issue and it happened on the same patient, so it took them 3 foleys for one patient.The foley catheter was blowing up right below the lurelock, not allowing them to blow up the balloon during a routine foley change.The patient had to have multiple foleys inserted until one worked, and it was not a great experience.
Additional Manufacturer Narrative
Per investigation findings, it has been determined that this mdr event is not reportable.H11:section a through f - 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 the customer had 2 foley catheters that had an issue and it happened on the same patient, so it took them 3 foleys for one patient.The foley catheter was blowing up right below the lurelock, not allowing them to blow up the balloon during a routine foley change.The patient had to have multiple foleys inserted until one worked, and it was not a great experience.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15616782
• Report Number: 1018233-2022-07893
• Device Sequence Number: 12784097
• Product Code: EZL
• UDI-Device Identifier: 00801741039201
• UDI-Public: (01)00801741039201
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2023

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: 04/30/2022
• Device Model Number: 806522
• Device Catalogue Number: 806522
• Device Lot Number: NGBU0920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 02/23/2023; 03/22/2023
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 02/23/2023; 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• 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