MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD URINE METER WITH BAG; URINE METER DRAIN BAG

Model Number 153204

Device Problems Restricted Flow rate (1248); No Flow (2991)

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

Event Date 06/26/2020

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 urine would not drain from the front plastic measuring box to the back overflow bag.It was also stated that even with manipulation of the bag from the opening of the collection meter, the urine did not drain.It seemed air locked as the burping valve on top left corner of collection meter got wet.

Manufacturer Narrative

The reported event was unconfirmed, as the problem could not be reproduced.There were no specifications for this exact failure, however the reported failure was considered within the specifications because the reported issue was unconfirmed.Visual evaluation of the returned sample noted that one opened (no original packaging), used meter bag was received.Visual inspection of the sample noted no obvious visual defects were observed.The meter was filled with the methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and was tilted.The solution transferred in the rest of the drainage bag easily as intended.The device was not related to the reported failure as the failure was unconfirmed.The investigation indicated that the reported issue was not manufacturing or supplier related.Therefore, a device history record review was not required.The instructions for use were found adequate and state the following: "directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use.1.Remove protective cap from drainage 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.3.Use sheeting clip to secure drainage tube to sheet.Important: hang drainage tube in a straight fashion from bedside to drainage bag.4.The urine meter may be emptied in two ways: a.To empty into the bag, grasp the bottom of the meter and lift up.To ensure that the meter empties completely, lifting again is recommended.B.To empty urine meter into receptacle, twist green portion of drain valve to the left; to close, twist green portion of the drain valve to the right.5.To empty bag: a.To remove outlet tube from housing; gently squeeze connector arms and pull tube from housing.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.6.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.7.If bag is not positioned correctly, urine may bypass the meter and go directly to the bag.Reposition bag as necessary.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." 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 urine would not drain from the front plastic measuring box to the back overflow bag.It was also stated that even with the manipulation of the bag from the opening of the collection meter, the urine would not drain.It seems the air locked as the burping valve on the top left corner of the collection meter got wet.

• Brand Name: BARD URINE METER WITH BAG
• Type of Device: URINE METER DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10307795
• MDR Text Key: 200803703
• Report Number: 1018233-2020-04674
• Device Sequence Number: 1
• Product Code: KNX
• UDI-Device Identifier: 00801741033117
• UDI-Public: (01)00801741033117
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 153204
• Device Catalogue Number: 153204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1