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

Catalog Number	154114A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was confirmed - cause unknown.Received 1 drainage bag with inlet tube, sample port connector and foley catheter with syringe attached.Verified date code 6517ki.Visual inspection noted the blue stem was disconnected.Product labeling was reviewed for this investigation.The reported event is addressed within the labeling.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Udi format updated with available product information per gudid.H11: sections 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 sample port fell out of closed system drain bag.A specimen port spontaneously fell out of the system's drainage tubing, resulting in an open system, and requiring a reinsertion.Customer also attached an image below showing the blue specimen/sample port having spontaneously fell out.Staff reported they did not manipulate the port in any way prior to finding it like this.In the image you can just make out how the staff found the device with the blue valve separate from the catheter drainage tubing.Customer used a standard foley drainage bag.Per follow up information received via email on 04feb2026, it was reported that the some of the lot/sn information had worn/rubbed off and i was and still am unable to decipher.There was patient impact related to the use of this device and the medical intervention was required.It was unknown what medical intervention was provided.The foley had to be removed.No troubleshooting was attempted, the system was open and the specimen port that ¿fell out¿ as contaminated at that point, so the foley had to be removed.

• Brand Name: BARD® URINARY DRAINAGE BAG
• 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 ; 7707846100
• MDR Report Key: 24408100
• Report Number: 1018233-2026-01113
• Device Sequence Number: 13221584
• Product Code: KNX
• UDI-Device Identifier: 00801741029547
• UDI-Public: (01)00801741029547
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 154114A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 100 KG