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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® LUBRICATH® FOLEY CATHETER; BARDEX FOLEY
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® LUBRICATH® FOLEY CATHETER; BARDEX FOLEY Back to Search Results
Model Number 907716
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event or Problem Description
It was reported that the catheter was leaking.
 
Additional Manufacturer Narrative
Per additional information received, it was determined that the reported event was non-reportable.
 
Event or Problem Description
It was reported that the catheter was leaking.
 
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Brand Name
BARD® LUBRICATH® FOLEY CATHETER
Common Device Name
BARDEX FOLEY
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7024841
Report Number1018233-2017-05831
Device Sequence Number10999057
Product Code EZC
UDI-Device Identifier00801741024184
UDI-Public(01)00801741024184
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K910846
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 11/14/2017
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
Operator of Device Health Professional
Device Model Number907716
Device Catalogue Number365716
Device Lot NumberNGBR3078
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 10/26/2017
Supplement Date Received by Manufacturer11/14/2017
Initial Report FDA Received Date11/13/2017
Supplement Report FDA Received Date11/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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