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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; FOLEY CATHETER (SILICONE)
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE) Back to Search Results
Catalog Number 176818
Device Problem Difficult to Remove (1528)
Patient Problems Pain (1994); Discomfort (2330); Hematuria (2558); No Code Available (3191)
Event Date 11/30/2020
Event Type  Injury  
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 two foley catheters were hard to remove which were placed in or on transplant patients.It was further reported that the catheter came out intact but caused some extra pain to the patients related to that small lip or bump the catheter had.Also stated that it has happened once or twice every year where the catheter kind of collapsed on itself.Per follow up via email on 03dec2020, customer stated that there were 3 catheters affected and used on 3 (male) patients.Three patient had experienced pain at removal site.Two patients received oral pain medication after removal and all three patients had some hematuria that resolved quickly within the hour.Per follow up information received on 14dec2020, customer stated that, patient was admitted for kidney transplant.And 18 french foley was used and nurse had removed the catheter with difficulty as it seemed to ¿catch¿ or ¿stick¿ towards the end of removal and the catheter had lip/bump towards the tip which caused the catching to occur.After several attempt it was able to remove and patient experienced discomfort during & immediately after removal, but it was resolved.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: b,f,h.
 
Event Description
It was reported that the two foley catheters were hard to remove which were placed in or on transplant patients.It was further reported that the catheter came out intact but caused some extra pain to the patients related to that small lip or bump the catheter had.Also stated that it was happened a time or two every year like before where the catheter kind of collapsed on itself.Per follow up via email on (b)(6) 2020, customer stated that there were 3 catheters were affected and used on 3 (male) patients.Three patient had experienced pain at removal site.Two patients were received oral pain medication after removal and all three patients had some hematuria that resolved quickly within the hour.Per follow up information received on (b)(6) 2020, customer stated that, patient was admitted for kidney transplant.And 18 french foley was used and nurse had remove the catheter with difficulty as it seemed to ¿catch¿ or ¿stick¿ towards the end of removal and the catheter had lip/bump towards the tip which caused the catching to occur.After several attempt it was able to remove and patient experienced discomfort during & immediately after removal, but it was resolved.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
 
Event Description
It was reported that the two foley catheters were hard to remove which were placed in or on transplant patients.It was further reported that the catheter came out intact, but caused some extra pain to the patients related to that small lip or bump the catheter had.Also stated that it was happened a time or every two years like before where the catheter was kind of collapsed on itself.Per follow-up via email on 03dec2020, the customer stated that there were 3 catheters affected and used in 3 (male) patients.The three patients had experienced pain at the removal site.The two patients were receiving oral pain medication after removal and all the three patients had some hematuria that resolved quickly within the hour.Per follow-up information received on 14dec2020, the customer stated that the patient was admitted for a kidney transplant.And 18 french foley was used and the nurse had removed the catheter with difficulty as it seemed to catch or sticky towards the end of removal and the catheter had a lip/bump towards the tip which caused the catching to occur.After several attempts the catheter was able to remove and the patient experienced discomfort during & immediately after removal, but it was resolved.
 
Event Description
It was reported that the two foley catheters were hard to remove which were placed in or on transplant patients.It was further reported that the catheter came out intact but caused some extra pain to the patients related to that small lip or bump the catheter had.Also stated that it has happened once or twice every year where the catheter kind of collapsed on itself.Per follow up via email on 03dec2020, customer stated that there were 3 catheters affected and used on 3 (male) patients.Three patient had experienced pain at removal site.Two patients received oral pain medication after removal and all three patients had some hematuria that resolved quickly within the hour.Per follow up information received on 14dec2020, customer stated that, patient was admitted for kidney transplant.And 18 french foley was used and nurse had removed the catheter with difficulty as it seemed to ¿catch¿ or ¿stick¿ towards the end of removal and the catheter had lip/bump towards the tip which caused the catching to occur.After several attempt it was able to remove and patient experienced discomfort during and immediately after removal, but it was resolved.
 
Manufacturer Narrative
The reported event was confirmed as manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley.Visual inspection of the sample noted that the balloon was mushroomed upon receipt.The catheter balloon was inflated with 30 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and very little made it into the balloon.It could be seen through the balloon that the inflation notch was not completely perforated, which would cause deflation issues as well.This did not meet the specification "notch not to penetrate drainage lumen and must be properly formed, inflation lumen no nicks allowed".It was also noted that since the notch not completely perforated, the balloon mushrooming would be a cascading issue due to the difficulty to deflate.A potential root cause for this failure could be ¿inadequate pressure on the machine to punch¿.The device history record was reviewed and found a possible manufacturing issue(s) 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.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.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.H3 other text : the actual/suspected device was inspected.
 
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Brand Name
BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER
Type of Device
FOLEY CATHETER (SILICONE)
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11056977
MDR Text Key243969765
Report Number1018233-2020-21911
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K984084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup,Followup,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number176818
Device Lot NumberNGDY2743
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Date Manufacturer Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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