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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® ALL-SILICONE TEMP SENSING FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER Back to Search Results
Model Number 119216M
Device Problems Material Deformation (2976); Material Integrity Problem (2978)
Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)
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 catheter was removed from a patient and had a knot in it.There was some bleeding from the patient once the catheter was removed.No medical intervention was required.The complainant believed the catheter was in place for less than 48 hours.
 
Manufacturer Narrative
The reported event was confirmed.Visual inspection noted one photo sample was received.Visual evaluation of the photo sample noted the catheter's shaft was in a knot.This failed to meet specifications per the standard which states the shaft must not be damaged or pinched.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be incorrect catheter positioning/ restraint.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 bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip syringes (fig.1b).1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.(fig.2) 3.Using aseptic technique, position the syringe in the center of the sampling port.Press the syringe firmly and twist gently to access the sampling port.(fig.3) 4.Slowly aspirate urine sample into syringe and remove syringe from sample port.5.Unkink tubing if necessary and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab.Bard, ez-lok and statlock are trademarks and/or registered trademarks of c.R.Bard, inc.©2018 c.R.Bard, inc.All rights reserved.Pk7646068 05/2018 www.Bardmedical.Com manufacturer: bard medical division c.R.Bard, inc.8195 industrial blvd.Covington, ga 30014 usa 1.800.526.4455 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 resterilize.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.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 patient record proper techniques for urinary catheter maintenance ¿ 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 (e.G., prior to transport) using a separate, clean collection container for each patient ¿ routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate ¿ leave foley catheter in place only as long as needed ez-lok® sampling port fig.3 fig.2 fig.1a fig.1b sterilized using ethylene oxide".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 catheter was removed from a patient and had a knot in it.There was some bleeding from the patient once the catheter was removed.No medical intervention was required.The complainant believed the catheter was in place for less than 48 hours.
 
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Brand Name
BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER
Type of Device
TEMP SENSING FOLEY
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9992587
MDR Text Key188982505
Report Number1018233-2020-02789
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741046308
UDI-Public(01)00801741046308
Combination Product (y/n)N
PMA/PMN Number
K070582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 06/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number119216M
Device Catalogue Number119216M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2020
Date Manufacturer Received05/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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