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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL FOLEY CATHETER; UNKNOWN FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL FOLEY CATHETER; UNKNOWN FOLEY CATHETER Back to Search Results
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2022
Event Type  malfunction  
Event Description
It was reported that the survey respondent mentioned about bacteriuria and catheter blockage when they were asked of complications faced while using the bard lubrisil hydrogel coated silicone foley catheter.It was unknown what medical intervention was provided.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿lumen wall thickness undersized".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the (foley catheter) product ifus were found to be adequate based on past reviews.The device was not returned.
 
Event Description
It was reported that the survey respondent mentioned about bacteriuria and catheter blockage when they were asked of complications faced while using the bard lubrisil hydrogel coated silicone foley catheter.It was unknown what medical intervention was provided.
 
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Brand Name
LUBRI-SIL FOLEY CATHETER
Type of Device
UNKNOWN FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key14187081
MDR Text Key289899061
Report Number1018233-2022-02830
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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