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

Catalog Number 0165L14

Device Problems Burst Container or Vessel (1074); Decrease in Pressure (1490); Device Dislodged or Dislocated (2923); Unintended Deflation (4061)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the catheter balloon had burst three times on different days.It was also stated that most recently on (b)(6) 2020 the patient got pain with no pattern as to when it occurred and had a tremendous desire to pass urine and felt like the catheter exploded.It was also reported that the catheter fell out of the patient and on check of the catheter balloon burst was found.On (b)(6) 2020, the catheter fell out with severe pain to the patient.On (b)(6) 2020, the catheter fell out with balloon deflated.Catheter with lot number ngdz0222 inserted on (b)(6) 2020 was blocked.Catheter with lot number ngdz0222 inserted on (b)(6) 2020 had balloon burst with no visible encrustation.It was also stated that there had been other changes for bypassing but no records of encrustation in notes.When checked the paper record on site 3 of the 4 changes of catheter were ngdz0222 exp 3/12/2022.There was no issue with storage of catheters.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.Potential root cause for this failure mode could be user related (example: contact with sharp object)/mechanical failure/operator error/thin rubberize layer).The lot number was unknown; therefore, the device history record could not be reviewed.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.Do not resterilize single use only.Do not reuse.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Consult instructions for use.Do not use if package is damaged." 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.H3 other text : the device was not returned.

Event Description

It was reported that the catheter balloon had burst three times on different days.It was also stated that most recently on (b)(6)2020 the patient got pain with no pattern as to when it occurred and had a tremendous desire to pass urine and felt like the catheter exploded.It was also reported that the catheter fell out of the patient and on check of the catheter balloon burst was found.On (b)(6)2020, the catheter fell out with severe pain to the patient.On (b)(6)2020, the catheter fell out with balloon deflated.Catheter with lot number ngdz0222 inserted on (b)(6)2020 was blocked.Catheter with lot number ngdz0222 inserted on (b)(6)2020 had balloon burst with no visible encrustation.It was also stated that there had been other changes for bypassing but no records of encrustation in notes.When checked the paper record on site 3 of the 4 changes of catheter were ngdz0222.There was no issue with storage of catheters.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10568558
• MDR Text Key: 208759652
• Report Number: 1018233-2020-06124
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

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: Health Professional
• Device Catalogue Number: 0165L14
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 12/24/2020
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1