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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER Back to Search Results
Model Number 175816
Device Problems Inflation Problem (1310); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problems Patient Problem/Medical Problem (2688); 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.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.
 
Event Description
It was reported that the rn placed the foley catheter but could not inflate the balloon more than 3ml before meeting resistance.The foley was in as far as it would go.Both the physician assistant and the surgeon tried.The staff then tried to empty the balloon and could not.When trying to remove the foley, resistance was met.They tried multiple times to fully deflate the balloon and still met resistance.The device was then removed.Once it was removed, the surgeon still could not fully deflate the balloon.The patient had a small amount of bleeding from the foley being removed with a partially inflated balloon.
 
Event Description
It was reported that the rn placed the foley catheter but could not inflate the balloon more than 3ml before meeting resistance.The foley was in as far as it would go.Both the physician assistant and the surgeon tried.The staff then tried to empty the balloon and could not.When trying to remove the foley, resistance was met.They tried multiple times to fully deflate the balloon and still met resistance.The device was then removed.Once it was removed, the surgeon still could not fully deflate the balloon.The patient had a small amount of bleeding from the foley being removed with a partially inflated balloon.
 
Manufacturer Narrative
The reported event was confirmed.Visual inspection noted one two-way foley catheter was received with the meter bag attached.Visual evaluation noted no obvious defects.It was attempted to inflate the balloon with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).It was noticeably difficult to attempt to push solution into the balloon.It was then attempted to deflate what solution was able to make it into the balloon and was unable to do so.The balloon was then dissected to find that the inflation notch was not completely perforated.This is considered a failure per inspection procedure stating that the notch punch should be complete.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be inadequate pressure on the machine to punch.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: "visually inspect the product for any imperfections or surface deterioration prior to use.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.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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." 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® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9777101
MDR Text Key184893572
Report Number1018233-2020-01477
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741034169
UDI-Public(01)00801741034169
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number175816
Device Catalogue Number175816
Device Lot NumberNGDQ4281
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2020
Date Manufacturer Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
Patient Weight88
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