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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER; SILICON FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER; SILICON FOLEY CATHETER Back to Search Results
Model Number 1758SI16
Device Problems Material Puncture/Hole (1504); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2020
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 the foley was inserted for first case and failed.Then second foley was inserted and balloon was instilled with fluid using syringe to fill to 10ml.The syringe became disconnected which caused half of fluid to not go into balloon.Then the foley was gently pulled until resistance felt from balloon.Also the urine leaked from around foley site and foley fell out to floor with balloon completely deflated.Balloon was not pre-inflated as per manufacturer instructions.The balloon was tested and clearly had a hole in it.Patient had to be flipped back to supine position and another catheter was inserted.
 
Manufacturer Narrative
The reported event was confirmed however the cause was unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley catheter with meter bag, inlet tubing, sample port connector, and syringe.Visual inspection of the sample noted no obvious visible defects.The syringe was inserted into the inflation port of the catheter with no observed issues.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100 ml distilled water) and solution immediately leaked from a 0.1285" hole found in the balloon surface.This was out of specification per inspection procedure which states, "pinholes are not permitted".A potential root cause for this failure could be imperfection in balloon due to process.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: "sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not re-sterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Proper techniques for urinary catheter insertion perform hand hygiene immediately before and after insertion insert urinary catheters using aseptic technique and sterile equipment use the smallest foley catheter possible, consistent with good drainage document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record * generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.To assist in healing of open sacral or perineal wounds, patient requires prolonged immobilization, to improve comfort for end of life care, patient has acute urinary retention or bladder outlet obstruction, need for accurate urine output measurements, use for selected surgical procedures.Secure the foley catheter.Use the statlock® foley stabilization device if provided maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions maintain unobstructed urine flow and keep the catheter and collection tube free from kinking keep the collection bag below the level of the bladder or hips at all times empty the collection bag regularly using a separate, clean collection container for each 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.
 
Event Description
It was reported that the foley was inserted for first case and failed.Then second foley was inserted and balloon was instilled with fluid using syringe to fill to 10ml.The syringe became disconnected which caused half of fluid to not go into balloon.Then the foley was gently pulled until resistance felt from balloon.Also, the urine leaked from around foley site and foley fell out to floor with balloon completely deflated.Balloon was not pre-inflated as per manufacturer instructions.The balloon was tested and clearly had a hole in it.Patient had to be flipped back to supine position and another catheter was inserted.Per follow up via phone on 26feb2021, the first foley catheter was inserted, and it was noted that urine was leaking around the foley site and the catheter fell out of the patient with the balloon completely deflated.The balloon was later tested and noted to have a hole in it.Another catheter was placed, but the syringe disconnected while instilling fluid into the balloon so the syringe from the first kit was used to inflate the balloon on the second catheter.
 
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Brand Name
BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER
Type of Device
SILICON FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key10932771
MDR Text Key219138866
Report Number1018233-2020-21278
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741025228
UDI-Public(01)00801741025228
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1758SI16
Device Catalogue Number1758SI16
Device Lot NumberNGET3117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Date Manufacturer Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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