MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® LARGE NYLON CATHETER PLUG

Catalog Number	0414L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a foley, drain bag and foley plug.Patient has been getting infections constantly and would like to know how to clean the foley plug better.Upon troubleshooting, it was noted that the patient was using rusch foley, cardinal drainage bag and bd foley plug, 0414l.Explained we have no cleaning information for this plug and it was non-sterile.Suggested a sterile foley plug from medline and reach out to her hcp.Caller was unhappy with this information and hung up.Forwarded information to complaints.It is unknown what medical information was provided.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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 patient had a foley, drain bag and foley plug.Patient has been getting infections constantly and would like to know how to clean the foley plug better.Upon troubleshooting, it was noted that the patient was using rusch foley, cardinal drainage bag and bd foley plug, 0414l.Explained we have no cleaning information for this plug and it was non-sterile.Suggested a sterile foley plug from medline and reach out to her hcp.Caller was unhappy with this information and hung up.Forwarded information to complaints.No medical intervention was reported.
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 labeling is found to be adequate.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: h.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.

• Brand Name: BARD® LARGE NYLON CATHETER PLUG
• Common Device Name: CATHETER PLUG
• 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: 23330333
• Report Number: 1018233-2025-09315
• Device Sequence Number: 18619249
• Product Code: KNY
• UDI-Device Identifier: 10801741046244
• UDI-Public: (01)10801741046244
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: Health Professional
• Device Catalogue Number: 0414L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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