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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; FOLEY CATHETER (LATEX)

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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER; FOLEY CATHETER (LATEX) Back to Search Results
Model Number 0165SI14
Device Problems Inaccurate Flow Rate (1249); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 11/15/2018
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 there was no urine flow.After the catheter was replaced, approximately 1000 ml of urine came out.
 
Manufacturer Narrative
The reported event was unconfirmed since the problem could not be reproduced.The evaluation found no blockage in the drainage lumen.Water was introduced through the drainage eye and came out from the drainage funnel without difficulty.Sample was sent for flow rate test and passed.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: ¿(1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1)patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter.".
 
Event Description
It was reported that there was no urine flow.After the catheter was replaced, approximately 1000 ml of urine came out.
 
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Brand Name
BARDEX® I.C. FOLEY CATHETER
Type of Device
FOLEY CATHETER (LATEX)
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8150859
MDR Text Key130057872
Report Number1018233-2018-05963
Device Sequence Number1
Product Code MJC
UDI-Device Identifier00801741016745
UDI-Public(01)00801741016745
Combination Product (y/n)N
PMA/PMN Number
K910318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2021
Device Model Number0165SI14
Device Catalogue Number0165SI14
Device Lot Number8FX8051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2018
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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