MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. COMPLETE CARE URINE METER FOLEY TRAY; DRAIN BAG 1532300J IS PART OF THE TRAY 7730014L

Catalog Number 903014A

Device Problems Restricted Flow rate (1248); Infusion or Flow Problem (2964)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2020

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 urine stagnated in the inlet tube and the urine was difficult to flow.It was further reported that the urine was difficult to transfer from meter to drainage bag.

Event Description

It was reported that the urine stagnated in the inlet tube and the urine was difficult to flow.It was further reported that the urine was difficult to transfer from meter to drainage bag.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.However, the potential root cause for this failure mode could be a defect contributed by vendor or supplier (eg: design of the device) or user related (eg: high urinary calcium).The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "8) keep the drainage bag below the bladder level without touching the floor.9) connect the lead wire of catheter to temperature monitor with extension cable.10) secure drainage tube to bed sheet with clip to ensure that there is neither twist nor kink in the tube.11) to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered. 1) occlude drainage tubing a minimum of 10 cm below the sampling port by kinking the tubing until urine fills the tubing up to near (slightly above) the sampling port.2) swab surface of site with antiseptic wipe.3) using aseptic technique, position the needle less syringe (slip-tip type or luer-lock type) in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port.Press the syringe and twist to lock the syringe onto the sampling port.4) aspirate desired volume of urine.After sampling, detach the syringe.Ensure that the rubber stem of the sampling port has returned to its original position.5) unkink tubing. catheter is pre-connected to ez-lok®, and the connecting part is covered with red seal (tamper-evident seal).Remove the seal by grasping the tab at the end of the seal and pulling along perforations, and then disconnect the catheter and the tubing using aseptic technique.12) when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.13) when deflating balloon, do not aspirate with a syringe by hands.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.] 14) do not stretch catheter as damage to or dislodgement of lead wire as temperature probe may cause improper temperature measurement.15) when endoelectric surgery is performed, care should be taken to prevent burns in the local tissue.16) do not wet the lead wire and the junction with extension cable.17) this device is compatible only with monitors requiring ysi 400-series type temperature probes.18) no substance except sterile water should be used to inflate the balloon.[if contrast medium is used, balloon may burst.If normal saline is used, crystallized salt may occlude the inflation lumen to prevent deflation of the balloon.If air is used, air may escape to cause inadvertent deflation of the balloon so that the catheter may come out prematurely.] 19) do not wipe catheter surface with organic solvents such as alcohol.20) do not aspirate urine through drainage funnel wall.21) since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.22) when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.23) avoid force on the connecting parts as they may be accidentally disconnected due to the weight of the drainage bag etc.And may cause urine spill.24) do not pull or twist the outlet tube.Also, do not squeeze the drainage bag.[the joint of the drainage bag and the outlet tube may be damaged and urine leakage may occur.] 25) when disposing of urine, observe the following: 1) remove the outlet tube from the housing of the urine drainage bag.2) lift the green lever to open while holding the outlet tube.Be careful not to pull the outlet tube when lifting the green lever.3) when disposal of urine is completed, close the green lever and put the outlet tube into the housing." 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.

• Brand Name: BARDEX I.C. COMPLETE CARE URINE METER FOLEY TRAY
• Type of Device: DRAIN BAG 1532300J IS PART OF THE TRAY 7730014L
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10431117
• MDR Text Key: 204340766
• Report Number: 1018233-2020-05299
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 903014A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1