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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER Back to Search Results
Catalog Number 165816
Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182); Physical Resistance/Sticking (4012)
Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 06/28/2019
Event Type  malfunction  
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 catheter was inserted and urine would not drain out.The nurse removed the catheter and checked it, when 10ml water was injected into the inflation tube to fill balloon the balloon only filled on one side.Per email received from ibc representative on (b)(6) 2019, the catheter was stored flat in the box from the supplier (mass) along with other goods, such as catheter packs etc.On inspection prior to use, the catheter appeared normal.The user used to test balloon prior to insertion however this practice was ceased on written protocol and catheter insertion procedures.Sterile water, steri-amp, 10ml ampule from promed catheter pack pmdl6920.3, lot 26707, exp 09/2019 was used to fill the balloon.Flow noted on insertion, balloon filled, resistance greater than normal balloon resistance, was not felt.Client did not express pain on balloon inflation.After client stood, had a glass of fluid and waited approximately 20-25 minutes, no further flow was noted.There were steps taken to get urine to flow before removing the catheter such as flushing the catheter with 50mls of sodium chloride 0.9%, but still no drainage.The user then deflated the balloon to check the quantity of fluid in balloon.When the user removed the catheter a blood clot was pulled from the catheter tip.The user was concerned so the balloon was checked post removal.And not sure how the blood is related to the catheter.The lack of pain voiced by the client with little resistance from balloon inflation lead them to believe that the catheter tip was in correct placement.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿blocked lumen¿.A potential root cause for this failure could be "biological deposits".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: ¿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: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.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 syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.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.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Bard and bardex are registered trademarks of c.R.Bard, inc.Or an affiliate.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.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.".
 
Event Description
It was reported that the catheter was inserted and urine would not drain out.The nurse removed the catheter and checked it, when 10ml water was injected into the inflation tube to fill balloon the balloon only filled on one side.Per email received from ibc representative on 10-july-19, the catheter was stored flat in the box from the supplier (mass) along with other goods, such as catheter packs etc.On inspection prior to use, the catheter appeared normal.The user used to test balloon prior to insertion however this practice was ceased on written protocol and catheter insertion procedures.Sterile water, steri-amp, 10ml ampule from promed catheter pack pmdl6920.3, lot 26707, exp 09/2019 was used to fill the balloon.Flow noted on insertion, balloon filled, resistance greater than normal balloon resistance, was not felt.Client did not express pain on balloon inflation.After client stood, had a glass of fluid and waited approximately 20-25 minutes, no further flow was noted.There were steps taken to get urine to flow before removing the catheter such as flushing the catheter with 50mls of sodium chloride 0.9%, but still no drainage.The user then deflated the balloon to check the quantity of fluid in balloon.When the user removed the catheter a blood clot was pulled from the catheter tip.The user was concerned so the balloon was checked post removal.And not sure how the blood is related to the catheter.The lack of pain voiced by the client with little resistance from balloon inflation lead them to believe that the catheter tip was in correct placement.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿blocked lumen¿.A potential root cause for this failure could be "biological deposits".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: ¿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: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.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 syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.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.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Bard and bardex are registered trademarks of c.R.Bard, inc.Or an affiliate.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.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.".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 the catheter was inserted and urine would not drain out.The nurse removed the catheter and checked it, when 10ml water was injected into the inflation tube to fill balloon the balloon only filled on one side.Per email received from ibc representative on 10-july-19, the catheter was stored flat in the box from the supplier (mass) along with other goods, such as catheter packs etc.On inspection prior to use, the catheter appeared normal.The user used to test balloon prior to insertion however this practice was ceased on written protocol and catheter insertion procedures.Sterile water, steri-amp, 10ml ampule from promed catheter pack pmdl6920.3, lot 26707, exp 09/2019 was used to fill the balloon.Flow noted on insertion, balloon filled, resistance greater than normal balloon resistance, was not felt.Client did not express pain on balloon inflation.After client stood, had a glass of fluid and waited approximately 20-25 minutes, no further flow was noted.There were steps taken to get urine to flow before removing the catheter such as flushing the catheter with 50mls of sodium chloride 0.9%, but still no drainage.The user then deflated the balloon to check the quantity of fluid in balloon.When the user removed the catheter a blood clot was pulled from the catheter tip.The user was concerned so the balloon was checked post removal.And not sure how the blood is related to the catheter.The lack of pain voiced by the client with little resistance from balloon inflation lead them to believe that the catheter tip was in correct placement.
 
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Brand Name
BARDEX® ALL-SILICONE FOLEY CATHETER
Type of Device
SILICONE FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8807206
MDR Text Key151863233
Report Number1018233-2019-04063
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 company representative,health
Type of Report Initial,Followup,Followup
Report Date 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/01/2023
Device Catalogue Number165816
Device Lot NumberMYCSE576
Was Device Available for Evaluation? No
Date Manufacturer Received09/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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