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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER Back to Search Results
Catalog Number 0165SI18
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/09/2024
Event Type  malfunction  
Event Description
It was reported that foreign matter (dirt) was found on the tip of the foley catheter before use on the patient.Per internal comments received on 15jan2024, they noticed a light brownish oil-like shine on the tip of the catheter.It did not come off even if they rub it with their hands.
 
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 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 foreign matter (dirt) was found on the tip of the foley catheter before use on the patient.Per internal comments received on 15jan2024, they noticed a light brownish oil-like shine on the tip of the catheter.It did not come off even if they rub it with their hands.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, e.H11: section a through f - the information provided by bd represents all 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® I.C. FOLEY CATHETER
Type of Device
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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key18606154
MDR Text Key334788481
Report Number1018233-2024-00313
Device Sequence Number1
Product Code MJC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K910318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0165SI18
Device Lot NumberMYHN0132
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2023
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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