MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bard® Urinary Drainage Bag with Anti-Reflux Chamber; Drain Bag

Catalog Number	154002
Medical Device Problem Codes	Restricted Flow rate (1248); Component Misassembled (4004)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer stated the bd urine drainage bag with anti reflux chamber (2000 ml) did not function as intended.Although the product claimed to have an anti reflux chamber, urine flowed back into the tubing.For approximately 6 months to 1 year, special care had been taken while emptying the bag to prevent urine backflow; however, reflux still occurred and was reported to have led to urinary tract infections in the patient¿s son.It was further reported that if the bag was accidentally turned or tilted, urine flowed back into the tubing.This issue had not occurred previously and was inconsistent with the product¿s stated anti reflux feature.The customer emphasized that the malfunction compromised patient safety and product reliability, as urine reflux should not occur under normal conditions of use.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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.
Event or Problem Description
It was reported that the customer stated the bd urine drainage bag with anti reflux chamber (2000 ml) did not function as intended.Although the product claimed to have an anti reflux chamber, urine flowed back into the tubing.For approximately 6 months to 1 year, special care had been taken while emptying the bag to prevent urine backflow; however, reflux still occurred and was reported to have led to urinary tract infections in the patient¿s son.It was further reported that if the bag was accidentally turned or tilted, urine flowed back into the tubing.This issue had not occurred previously and was inconsistent with the product¿s stated anti reflux feature.The customer emphasized that the malfunction compromised patient safety and product reliability, as urine reflux should not occur under normal conditions of use.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling as it state: instructions 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 from drainage tube catheter adapter and connect drainage tube to catheter.2.Position hanger on bedside rail, using string or hook.3.Use sheeting clip to secure drainage tube to sheet.A.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.4.If using a urine meter, it 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 position of the drain valve to the right.5.To empty bag: a.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.D.If specimen is required, see instructions for using urine sampling port.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d,f,h all available udi information is being provided.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.

• Brand Name: Bard® Urinary Drainage Bag with Anti-Reflux Chamber
• Common Device Name: Drain Bag
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. Bard Inc. (Covington) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 25196366
• Report Number: 1018233-2026-03146
• Device Sequence Number: 18740724
• Product Code: KNX
• UDI-Device Identifier: 00801741029509
• UDI-Public: (01)00801741029509(11)260216(17)301231(10)NGLN0435
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 154002
• Device Lot Number: NGLN0435
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 06/04/2026; 09/24/2026
• Initial Report FDA Received Date: 05/17/2026
• Supplement Report FDA Received Date: 06/12/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 200 LB