MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 PureWick Urine Collection System Accessory Replacement Kit

Catalog Number	PWKIT03
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our team conducted a review of the reported event, with the available information to ensure the ongoing safety and performance of the product.As this investigation has already been performed for a similar complaint, another investigation is not necessary.An investigation has been completed using all information currently available.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures.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 customer called regarding no suctioning on the canister.A troubleshoot was conducted and there still was no suctioning, a p/u was placed on her behalf.It's unclear if lot number was requested.Used with male wicks.Unclear if medical intervention was provided.No additional information provided.

• Brand Name: PureWick Urine Collection System Accessory Replacement Kit
• Common Device Name: PureWick
• 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: 25538202
• Report Number: 1018233-2026-03922
• Device Sequence Number: 9358647
• Product Code: NZU
• UDI-Device Identifier: 00801741185380
• UDI-Public: (01)00801741185380(11)241011(17)280601(10)20240013
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: PWKIT03
• Device Lot Number: 20240013
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2026
• 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: 06/09/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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: Male