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

Model Number 0165V24S

Device Problems Decrease in Pressure (1490); Dent in Material (2526)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the balloon collapse into the catheter after inflation.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿shaft strength (materials of shaft is too soft and torsion occurs - not enough support) ¿.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.]" visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to inflate.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.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.Refer to direct unit label for sterilization method utilized bard, bardex, bardia, biocath and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.Or an affiliate.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations." the device was not returned.

Event Description

It was reported that the balloon collapse into the catheter after inflation.Per follow up on 13apr2021, the customer confirmed that the balloon formed a mushroom once inflated.

• Brand Name: BARDEX SILICONE COATED FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11620300
• MDR Text Key: 243977225
• Report Number: 1018233-2021-01912
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741039430
• UDI-Public: (01)00801741039430
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 0165V24S
• Device Catalogue Number: 0165V24S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 07/03/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other