Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 BARDIA® URETHRAL CATHETER; RED RUBBER INTERMITTENT CATHETER
  • 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 BARDIA® URETHRAL CATHETER; RED RUBBER INTERMITTENT CATHETER Back to Search Results
Model Number 802414
Device Problems Restricted Flow rate (1248); Misassembled (1398)
Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
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 the eyelet at the tip of the red rubber intermittent catheter was two times smaller than the eyelet in the previous and subsequently received samples of the catheter.The patient stated that he was unable to get the urine to drain from the red rubber intermittent catheters.Reportedly, the patient stated that he requested a new sample to compare and the eyelet in the new catheter was visibly larger as well.No medical intervention reported.
 
Event Description
It was reported that the eyelet at the tip of the red rubber intermittent catheter was two times smaller than the eyelet in the previous and subsequently received samples of the catheter.The patient stated that he was unable to get the urine to drain from the red rubber intermittent catheters.Reportedly, the patient stated that he requested a new sample to compare and the eyelet in the new catheter was visibly larger as well.No medical intervention reported.
 
Manufacturer Narrative
The reported event could not be confirmed.The condition of the photographed sample appeared to be unused.The evaluation of the eyelet size was inconclusive due to the receipt of a non-original sample.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "manufacturer: c.R.Bard, inc.Covington, ga 30014 1-800-526-4455 www.Bardmedical.Com assembled in mexico instructions for use indications for use: for urological use only.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: this product contains natural rubber latex which may cause allergic reactions.Warnings: ¿ on latex and red rubber catheters, do not use ointments or lubricants having a petrolatum base.They will damage latex.¿ visually inspect the product for any imperfections or surface deterioration prior to use.¿ reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to failure, and/or to injury, illness or death of the patient.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Adverse reactions urinary tract infection bleeding from the urethra irritation of the urethra instructions for intermittent catheters: 1.Wash your hands thoroughly with soap and water.2.Remove catheter from the pack.3.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.4.Gently insert rounded end of catheter into urethra.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BARDIA® URETHRAL CATHETER
Type of Device
RED RUBBER INTERMITTENT CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8083116
MDR Text Key127601448
Report Number1018233-2018-05508
Device Sequence Number1
Product Code KOC
UDI-Device Identifier00801741018350
UDI-Public(01)00801741018350
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 01/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number802414
Device Catalogue Number802414
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2018
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-