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 FOLEY CATHETER SILICONE COATED
  • 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 FOLEY CATHETER SILICONE COATED Back to Search Results
Model Number 123516A
Device Problem Difficult to Remove (1528)
Patient Problems No Patient Involvement (2645); Patient Problem/Medical Problem (2688)
Event Date 06/05/2020
Event Type  Injury  
Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.Potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe)/collapse lumen/sac close eye/valve damage.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The device the instructions for use were found adequate and state the following: ¿bardia foley catheter caution: this product contains natural rubber latex which may cause allergic reactions.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile unless package is opened or damaged warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Do not use if package is opened or damaged.Recommended inflation capacities 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.To deflate catheter balloon: gently insert a 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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact an 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.¿.
 
Event Description
It was reported that the water inside of the balloon could not be drained completely.
 
Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.Potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe)/collapse lumen/sac close eye/valve damage.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The device the instructions for use were found adequate and state the following: ¿bardia foley catheter caution: this product contains natural rubber latex which may cause allergic reactions.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile unless package is opened or damaged warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Do not use if package is opened or damaged.Recommended inflation capacities 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.To deflate catheter balloon: gently insert a 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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact an 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.¿ 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 water inside of the balloon could not be drained completely.It was later reported via mail on 09july2020 from the international business center, the urologist checked the remaining water in the balloon by ultrasound, and cut the catheter to let the water flow out.It was later reported via mail from ibc on 15jul2020 that the defect was found during testing.
 
Event Description
It was reported that the water inside of the balloon could not be drained completely.It was later reported via mail from the international business center, urologist checked the remaining water in the balloon by ultrasound and cut the catheter to let the water flow out.
 
Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.Potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe)/collapse lumen/sac close eye/valve damage.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The device the instructions for use were found adequate and state the following: ¿bardia foley catheter caution: this product contains natural rubber latex which may cause allergic reactions.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile unless package is opened or damaged warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Do not use if package is opened or damaged.Recommended inflation capacities 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.To deflate catheter balloon: gently insert a 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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact an 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.¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BARDIA FOLEY CATHETER SILICONE COATED
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10203544
MDR Text Key200622608
Report Number1018233-2020-04155
Device Sequence Number1
Product Code EZC
UDI-Device Identifier00801741095092
UDI-Public(01)00801741095092
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup
Report Date 08/03/2020
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 Other
Device Expiration Date04/28/2024
Device Model Number123516A
Device Catalogue Number123516A
Device Lot NumberMYDT0382
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/05/2020
Initial Date FDA Received06/26/2020
Supplement Dates Manufacturer Received07/09/2020
07/09/2020
Supplement Dates FDA Received07/21/2020
08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-