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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 COUNCILL MODEL
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER COUNCILL MODEL Back to Search Results
Model Number 0196L20
Device Problems Leak/Splash (1354); Material Deformation (2976); Device Handling Problem (3265)
Patient Problems No Consequences Or Impact To Patient (2199); 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 the catheter was deformed after the first month of use.Per additional information via email from ibc on 25aug2020, the patient is bedridden ad has been paralyzed since 2014.The catheter was placed transurethrally.Nacl 0.9% liquid was successively inserted starting with 10, 15, 20 and 25 fillings; an attempt was made to humidify the catheter tip for 5 minutes in nacl which has been successfully done with the portuguese ones.In spite of this, behavior was the same even after 1 month all catheters begins to leak.Regular catheter irrigation was performed and the patient was able to be re-catheterized.No sutures were used to anchor the catheter in the patient.There were no missing pieces.
 
Event Description
It was reported that the catheter was deformed after the first month of use.Per additional information via email from ibc on 25aug2020, the patient is bedridden ad has been paralyzed since 2014.The catheter was placed transurethrally.Nacl 0.9% liquid was successively inserted starting with 10, 15, 20 and 25 fillings; an attempt was made to humidify the catheter tip for 5 minutes in nacl which has been successfully done with the portuguese ones.In spite of this, behavior was the same even after 1 month all catheters begins to leak.Regular catheter irrigation was performed and the patient was able to be re-catheterized.No sutures were used to anchor the catheter in the patient.There were no missing pieces.Per notification received via investigator on 21oct2020, as the device was not intended to be used with saline.
 
Manufacturer Narrative
The reported event was confirmed.Two photo samples of a deformed catheter was returned.In one photo sample, the red rubber catheter appears to be placed into the packaging after use.The other photo sample shows that amber deformed foley catheter without the packaging.Only first photo appears to be consistent with the 0196l20 which is red rubber catheter.The second one catheter also appears to be consistent as 0196l20 has amber latex under the red rubber.When this catheter gets wet it the amber latex become impregnate with the water becoming more prevalent.According to the event, "nacl 0.9% liquid, successively tried 10, 15, 20 and 25 fillings and also tried to humidify catheter tip for 5 minutes in nacl, as used to do successfully with the portuguese ones." this device is not intended to be inflated with saline which can cause the deformation shown in both pictures; therefore the reported event will be confirmed as use-related.The device history record review was not required as the reported event was confirmed as use-related.The instructions for use were found adequate and state the following: "5cc balloon: use 10ml sterile water".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.
 
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Brand Name
BARDEX LUBRICATH FOLEY CATHETER COUNCILL MODEL
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10469256
MDR Text Key221864608
Report Number1018233-2020-05556
Device Sequence Number1
Product Code EZC
UDI-Device Identifier00801741017940
UDI-Public(01)00801741017940
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/28/2020
Device Model Number0196L20
Device Catalogue Number0196L20
Device Lot NumberNGBS0940
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2020
Date Manufacturer Received12/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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