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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL® I.C. FOLEY TRAY; CANADA URINE BAG
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C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL® I.C. FOLEY TRAY; CANADA URINE BAG Back to Search Results
Catalog Number 900114
Device Problems Restricted Flow rate (1248); Difficult to Open or Close (2921); No Flow (2991)
Patient Problems Abdominal Pain (1685); Pain (1994); Urinary Retention (2119); Discomfort (2330)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.The device was not returned.
 
Event Description
It was reported that urine got stuck in the tubing and did not drain into the drainage bag, which caused patient discomfort and pain from a full bladder.It appeared that the anti reflux valve did not open or just partially opened.This allegedly caused abdomen pain.
 
Event Description
It was reported that urine got stuck in the tubing and did not drain into the drainage bag, which caused patient discomfort and pain from a full bladder.It appeared that the anti reflux valve did not open or just partially opened.This allegedly caused abdomen pain.
 
Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿directions for use: 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.1.Remove protective cap fromdrainage tube catheter adapter and connect drainage tube to catheter.2.Position hanger on bedside rail near the foot of the bed using string or hook.Important: hang drainage tube in a straight fashion from bedside to drainage bag using sheeting clip to secure drainage tube to sheet.3.To empty bag: a.To remove outlet tube from housing, gently squeeze connector arms and pull tube fromhousing.B.Release clamp and empty bag.C.After emptying, reclamp outlet tube and slide connector into housing until connector arms engage.Note: if specimen is required, see directions for using urine sample port.4.Periodic observations of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed.Directions for using bard ez-lok® sampling port: bard ez-lok® sampling port accepts a luer-lock or slip tip syringe.1.Kink drainage tubing a minimum of 3 inches below the sampling port until urine is visible under the access site.2.Swab surface of site with antiseptic wipe.3.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80-100 degree angle).Press the syringe firmly and twist gently to lock the syringe onto the sampling port.Note: improper penetration technique could cause formation of a drop of urine on the surface of the sampling port.Periodic observation of the sampling port is recommended.4.Aspirate desired volume of urine.5.Unkink tubing and send specimen to laboratory.".
 
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Brand Name
LUBRI-SIL® I.C. FOLEY TRAY
Type of Device
CANADA URINE BAG
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7404592
MDR Text Key104811521
Report Number1018233-2018-01083
Device Sequence Number1
Product Code MJC
Combination Product (y/n)N
PMA/PMN Number
K984136
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Catalogue Number900114
Device Lot NumberNGBX3099
Was Device Available for Evaluation? No
Date Manufacturer Received04/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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