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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
Catalog Number 175816
Device Problem Inaccurate Flow Rate (1249)
Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/08/2021
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 silicone foley catheter did not drain properly.Per follow up response received on (b)(6) 2021, the surgery was delayed for the patient as the user had to take the catheter out and put another one in.The user had to stop the surgery and went under to place another which probably was not the most aseptic technique.The user was unsure if the baby was comprised by mother not getting to complete due to a full bladder.
 
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 silicone foley catheter did not drain properly.Per follow up response received on 15jan2021, the surgery was delayed for the patient as the user had to take the catheter out and put another one in.The user had to stop the surgery and went under to place another which probably was not the most aseptic technique.The user was unsure if the baby was comprised by mother not getting to complete due to a full bladder.
 
Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone foley catheter.Visual inspection of the sample noted no obvious visible defects.The drainage lumen was flushed with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), and solution could be seen temporarily sitting in the funnel before dripping into the rest of the drainage lumen.The solution dripped enough to build air pockets in the lumen while draining.The reported failure was considered out of specification as the reported failure was able to be reproduced.A potential root cause for this failure could be inadequate material selection.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: "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.H3 other text : the actual/suspected device was inspected.
 
Event Description
It was reported that the silicone foley catheter did not drain properly.Per follow up response received on 15jan2021, the surgery was delayed for the patient as the user had to take the catheter out and put another one in.The user had to stop the surgery and went under to place another which probably was not the most aseptic technique.
 
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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 30014
MDR Report Key11263593
MDR Text Key229810125
Report Number1018233-2021-00218
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 06/15/2021
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 Number175816
Device Lot NumberNGES1520
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Initial Date Manufacturer Received 01/08/2021
Initial Date FDA Received02/01/2021
Supplement Dates Manufacturer Received02/01/2021
06/15/2021
Supplement Dates FDA Received02/24/2021
07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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