• 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® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE)

  • 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® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE) Back to Search Results
Catalog Number 175818
Device Problems Biocompatibility (2886); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Ulceration (2116); Injury (2348); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the product did not performed as intended the respondent said "in most rare cases penile injury through ulceration occurs".The respondent also reported, "it increases the risk of having same problem after a long interval of time".
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿stylet tip protrudes through the tip.¿ with a potential root cause of "tip opening too large".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: ¿released c.R.Bard, inc.Covington, ga 30014 u.S.A.Made in mexico lubricious coating bonded to a bardex® foley catheter made of clear silicone elastomer pk7602585 04/2006 warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Unless package is opened or damaged.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities.Note: aggressive traction, particularly in the presence of suturing, is not recommended for silicone foley catheters.Bard, bardex and lubri-sil are registered trademarks of c.R.Bard, inc.Or an affiliate.U.S.Patent number 5,179,174 and patent pending.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Lubri-sil® all-silicone foley catheter peel to open" 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.H3 other text : the device was not returned.
 
Event Description
It was reported that the product did not performed as intended the respondent said "in most rare cases penile injury through ulceration occurs".The respondent also reported, "it increases the risk of having same problem after a long interval of time".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
Type of Device
FOLEY CATHETER (SILICONE)
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10028377
MDR Text Key189984070
Report Number1018233-2020-03039
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,study
Type of Report Initial,Followup
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number175818
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/16/2020
Initial Date FDA Received05/06/2020
Supplement Dates Manufacturer Received05/17/2020
Supplement Dates FDA Received05/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-