MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER; DRAIN BAG

Model Number 154002

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

It was reported that the customer previously used 153504 which had a better anti-reflux chamber.This bag had been discontinued and they were sent a new replacement, 154002.The new bag (154002) did not have a good anti-reflux chamber like the old one.They stated that when they tilted it upside down the urine or water poured out.Representative advised that the product 153504 was discontinued and the closest item would be the 154002 as they were sent, also informed patient that the bags are only meant to reduce backflow, not completely stop it, especially if upside down.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 : h3 other text : the device was not returned.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "incorrect assembly operation of drainage tube / anti-reflux chamber".It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device history record review could not be performed without a lot number.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 if any imperfection or surface deterioration is observed, do not use.Remove protective cap from drainage tube catheter adapter and connect drainage tube to catheter.Position hanger on bedside rail, using string or hook.Use sheeting clip to secure drainage tube to sheet.Important: hang drainage tube in a straight fashion from bedside to drainage bag.Ensure that the drainage bag is placed near the foot of the bed.If using a urine meter, it may be emptied in two ways: 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.To empty urine meter into receptacle, twist green portion of drain valve to the left; to close, twist green position of the drain valve to the right.To empty bag: remove outlet tube from housing; gently squeeze connector arms and pull tube from housing.Release clamp and empty bag.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.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.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.Kink drainage tubing a minimum of 3 inches below the sampling port until urine is visible under the access site.Swab surface of site with antiseptic wipe.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.Aspirate desired volume of urine.Unkink tubing and send specimen to laboratory.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.¿ h11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that the customer previously used 153504 which had a better anti-reflux chamber.This bag had been discontinued and they were sent a new replacement, 154002.The new bag (154002) did not have a good anti-reflux chamber like the old one.They stated that when they tilted it upside down the urine or water poured out.Representative advised that the product 153504 was discontinued and the closest item would be the 154002 as they were sent, also informed patient that the bags are only meant to reduce backflow, not completely stop it, especially if upside down.

• Brand Name: BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Type of Device: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16731624
• MDR Text Key: 313399508
• Report Number: 1018233-2023-02516
• Device Sequence Number: 1
• Product Code: KNX
• UDI-Device Identifier: 00801741029509
• UDI-Public: (01)00801741029509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 154002
• Device Catalogue Number: 154002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other