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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER Back to Search Results
Catalog Number 0165L12
Device Problem Failure to Infuse (2340)
Patient Problems Pain (1994); Pressure Sores (2326); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/28/2021
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 foley catheter broke at insertion and got stuck inside the patient.When the hospital staff was trying to inflate the balloon, they only managed to insert 5ml sterile water, the other 5ml settled at the valve, creating a new "balloon".They then tried to deflate the catheter but without success.They had to call a urologist and after 2 hours long attempt to deflate the catheter, they had to pull the inflated catheter out of the patient causing a bleeding.Patient was set with a hematuria catheter.It was not a major bleeding and the patient was fine at the moment but was very exhausted by the long procedure.The patient was experiencing soreness and had been provided with pain relief.It was unclear if the urinary tract had been damaged by the procedure.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure mode could be (example: manufacturing related due to operator error/ mechanical error/user related/mishandling product/thin rubberized layer).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, reseat 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." correction: h.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 foley catheter broke at insertion and got stuck inside the patient.When the hospital staff was trying to inflate the balloon, they only managed to insert 5ml sterile water, the other 5ml settled at the valve, creating a new balloon.They then tried to deflate the catheter but without success.They had to call a urologist and after 2 hours long attempt to deflate the catheter, they had to pull the inflated catheter out of the patient causing a bleeding.Patient was set with a hematuria catheter.It was not a major bleeding and the patient was fine at the moment but was very exhausted by the long procedure.The patient was experiencing soreness and had been provided with pain relief.It was unclear if the urinary tract had been damaged by the procedure.Per follow-up on 22feb2021, the staff noticed that the foley catheter was broken when trying to inflate the balloon.There were no known or visual damages to the packaging or product prior to insertion.The catheter worked fine during the insertion, there was a good urine flow.They noticed the catheter didn¿t inflate normally.There was a great resistance when trying to insert the sterile water.They only managed to insert a few millimeters when they noticed the water was starting to create a ¿new balloon¿ at the vault.The staff realized it was something wrong with the catheter and tried to deflate it to change it to a new one.They did not manage to deflate the balloon and had to call a urologist for assistance.The urologist tried to deflate the balloon, but the catheter was already broken.After various attempt to deflate the balloon, they had no other option but to pull it out with approx.3ml water left in the balloon.The patient was exhausted after the event as it took almost 2 hours, the patient had some minor bleedings (light red colour) for approximately 2 hours after the event and a hematuria was inserted.The hematuria catheter was changed to a regular catheter after one-two days (there was never a need to flush the hematuria during this time).The patient left the hospital with a regular catheter and no reports of any damages to the urinary tract have been reported after the event.
 
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Brand Name
BARDEX LUBRICATH FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11367955
MDR Text Key233191681
Report Number1018233-2021-00737
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0165L12
Device Lot NumberMYEU2352
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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