• Decrease font size
  • Return font size to normal
  • Increase font size
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)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER; FOLEY CATHETER (LATEX) Back to Search Results
Model Number 0165SI12
Device Problems Inaccurate Flow Rate (1249); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2020
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 observed inside the catheter on the next day of use.After both the catheter and the urine drainage bag were replaced, urine flowed as usual.Reportedly, on the day of use, the urine flow was normal.
 
Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduced.Evaluation found no blockage was observed in the drainage lumen.Water was introduced thru the drainage funnel and came out from drainage eye without difficulty.The sample was sent for a 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: "[warnings] 1.Method for use (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (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 [directions for use] 1.Method of use the device is intended for single use only and is not reusable.(6) insert catheter into the urethral meatus, and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.2.Precautions for use (1) when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.(2) when deflating balloon, do not aspirate with a syringe.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.] (3) no substance except sterile water should be used to inflate the balloon.[if contrast medium is used, balloon may burst.If normal saline is used, crystallized salt may occlude the inflation lumen to prevent deflation of the balloon.If air is used, air may escape to cause inadvertent deflation of the balloon so that the catheter may come out prematurely.] (4) do not wipe catheter surface with organic solvents such as alcohol.(5) do not aspirate urine through drainage funnel wall.(6) since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.(7) when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken." 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 there was no urine flow observed inside the catheter on the next day of use.After both the catheter and the urine drainage bag were replaced, urine flowed as usual.Reportedly, on the day of use, the urine flow was normal.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9682923
MDR Text Key183916269
Report Number1018233-2020-00870
Device Sequence Number1
Product Code MJC
UDI-Device Identifier00801741016738
UDI-Public(01)00801741016738
Combination Product (y/n)N
PMA/PMN Number
K910318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 03/11/2020
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 Expiration Date11/28/2022
Device Model Number0165SI12
Device Catalogue Number0165SI12
Device Lot Number9GH087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Initial Date Manufacturer Received 01/15/2020
Initial Date FDA Received02/07/2020
Supplement Dates Manufacturer Received03/08/2020
Supplement Dates FDA Received03/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-