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

Model Number	266726
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
It was reported that 3 bard foley catheters were injected with saline to inflate the balloon, and it was noted that the catheters ballooned out at the distal end just past the location where the syringe attaches.
Event or Problem Description
It was reported that 3 bard foley catheters were injected with saline to inflate the balloon, and it was noted that the catheters ballooned out at the distal end just past the location where the syringe attach.
Additional Manufacturer Narrative
The reported event was unconfirmed.Evaluation found all catheters can be inflated without difficulty.Dissected the catheter and found no conditions that would contribute to the reported problem.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: "warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.For urological use only.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.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.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, preventing balloon deflation.If necessary, 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.".

• Brand Name: BARD FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10354137
• Report Number: 1018233-2020-04937
• Device Sequence Number: 3220018
• Product Code: KOD
• UDI-Device Identifier: 00801741039744
• UDI-Public: (01)00801741039744
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 01/28/2024
• Device Model Number: 266726
• Device Catalogue Number: 266726
• Device Lot Number: MYDX1501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 08/01/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1