MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL; CONT IRRIGATION FOLEY CATHETER

Model Number 01267522

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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 during the evaluation of the sample, it was found that the catheter balloon would not deflate completely.

Event Description

It was reported that during the evaluation of the sample, it was found that the catheter balloon would not deflate completely.

Manufacturer Narrative

The reported event was confirmed, as manufacturing-related.One amber lubricath 75cc balloon catheter was returned without the original packaging.A luer lock syringe was used to inflate the catheter with 80cc of di water.No water leaks were noticed.The balloon was passively deflated.Water was found to remain in the balloon after deflation.This did not pass the functional evaluation.The potential root causes could be "dull cutting tools", "operator error", or "insufficient drying".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.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 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." 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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL
• Type of Device: CONT IRRIGATION FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10011665
• MDR Text Key: 189600313
• Report Number: 1018233-2020-02933
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741018817
• UDI-Public: (01)00801741018817
• Combination Product (y/n): N
• PMA/PMN Number: K910195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: 01267522
• Device Catalogue Number: 01267522
• Device Lot Number: MCDP6012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1