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

Catalog Number 154006

Device Problems Restricted Flow rate (1248); Insufficient Information (3190)

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

Event Date 07/25/2023

Event Type  malfunction  

Event Description

It was reported that customer noticed a design flaw in a urinary drain bag.Per follow up via email on (b)(6) 2023, patient was merely reporting findings based on personal experience with a bd urine collection bag.It was stated that after the trans urethral resection of bladder tumor surgery, a foley catheter was inserted and attached to a bard drainage bag.Under some conditions the bag may create a suction effect when drained.Which could lead to a bladder infection.After emptying the bag a third time, they noticed the bag was no longer limp.Instead of being filled with air above a pool of urine, the clear front and rear bag surfaces had collapsed together, sucking down the air vent.The air leak was effectively sealed shut and no longer assured the inside of the bag remained at atmospheric pressure.In addition, without a functional air relief valve, surface tension prevented air from leaking back into the bag through the drain when it was opened.As the urine was drained from the bag, a negative pressure inside the bag developed.It looked like a food-saver vacuum bag.This negative pressure sucked on the bladder, and could only be relieved by air leaking between the catheter and the urethra.Foamy urine was the result, but more concerning, the inward leak could transport bacteria into the body and trigger a urinary tract infection.Customer preference: one solution was to move the air vent so it could not be sealed inadvertently.They suggest moving it to the rear (white plastic) surface under the anti-reflux plenum.This would completely prevent a potentially serious reverse flow from ever re-occurring.Adding a vent to the rear surface was less convenient, but they feel it addressed an important safety issue.

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 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.

Manufacturer Narrative

The reported event was inconclusive due to poor photo sample.A potential root cause was not chosen due to a lack of information.It is 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.Visual evaluation of the returned photo sample noted one opened (without original packaging), used drainage bag.Visual inspection of the photo sample noted that the reported failure could not be evaluated, therefore this investigation is considered inconclusive.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: "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 imperfections or surface deterioration is observed, do not use.1.Remove protective cap from drainage tube catheter adapter and connect drainage tube to catheter.2.Unsnap hook.3.Position hanger on bedside rail near the foot of the bed using string or hook.4.Use sheeting clip to secure drainage tube to sheet.5.To empty bag: open- with thumb on top of device and finger under green lever, lift and rotate counterclockwise.Close-with thumb on green lever and finger on lever support bar, rotate lever clockwise.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.7.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.¿ 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.

Event Description

It was reported that customer noticed a design flaw in a urinary drain bag.Per follow up via email on (b)(6) 2023, patient was merely reporting findings based on personal experience with a bd urine collection bag.It was stated that after the trans urethral resection of bladder tumour surgery, a foley catheter was inserted and attached to a bard drainage bag.Under some conditions the bag may create a suction effect when drained.Which could lead to a bladder infection.After emptying the bag a third time, they noticed the bag was no longer limp.Instead of being filled with air above a pool of urine, the clear front and rear bag surfaces had collapsed together, sucking down the air vent.The air leak was effectively sealed shut and no longer assured the inside of the bag remained at atmospheric pressure.In addition, without a functional air relief valve, surface tension prevented air from leaking back into the bag through the drain when it was opened.As the urine was drained from the bag, a negative pressure inside the bag developed.It looked like a food-saver vacuum bag! this negative pressure sucked on the bladder, and could only be relieved by air leaking between the catheter and the urethra.Foamy urine was the result, but more concerning, the inward leak could transport bacteria into the body and trigger a urinary tract infection.

• 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: 17835378
• MDR Text Key: 324494948
• Report Number: 1018233-2023-07112
• Device Sequence Number: 1
• Product Code: KNX
• UDI-Device Identifier: 00801741029615
• UDI-Public: (01)00801741029615
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 154006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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