MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 PUREWICK¿ URINE COLLECTION SYSTEM ACCESSORY REPLACEMENT KIT WITH HANDLE

Catalog Number	PWKIT03H
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
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 customer states pw will not suction.Rep reset float valve -pw failed water cup test exchanging accessory kit if issue persist.Customer will need to purchase new unit oop warranty expired in 2024.No additional information provided.Troubleshooting did not resolved the issue.Bio box needed from field assurance for kits/wicks only.(prepping and placement tips shared).
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 states: 1.Check that the power cord is plugged into the purewick urine collection system and to an electrical outlet.2.Ensure the electrical outlet is functioning by plugging in another electrical device.3.Ensure tubing connections are connected properly.4.Check collector tubing for blockage or flow restriction such as pinched or kinked tubing.5.Ensure overflow stop valve in collection canister lid is open.The valve floats to the top when the collection canister is full.The stop valve may close if the lid or canister is tipped sideways or upside down.Disconnect tubing and gently shake the lid to reset the valve down to the open position.6.Ensure collection canister is sealed with the lid tightly closed.7.Verify suction by disconnecting purewick external catheter from the collector tubing and placing the end of the collector tubing into a cup of water.If water easily flows into the collection canister replace the purewick external catheter.If the purewick urine collection system is not functioning properly after performing the troubleshooting steps, the device may have reached the end of its useful life.With normal use, this device shall remain safe for the useful life.Do not use the device if it is damaged or defective, including, but not limited to the following: ¿ cracks.¿ separated housing.¿ not suctioning properly or no suction.¿ damaged power cord.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.
Event or Problem Description
It was reported that the customer states pw will not suction.Rep reset float valve.Pw failed water cup test exchanging accessory kit if issue persist.Customer will need to purchase new unit; oop warranty expired in 2024.No additional information provided.Troubleshooting did not resolved the issue.Bio box needed from field assurance for kits/wicks only.(prepping and placement tips shared).

• Brand Name: PUREWICK¿ URINE COLLECTION SYSTEM ACCESSORY REPLACEMENT KIT WITH HANDLE
• 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 ; 7707846100
• MDR Report Key: 23390563
• Report Number: 1018233-2025-09580
• Device Sequence Number: 10047164
• Product Code: NZU
• UDI-Device Identifier: 00801741185380
• UDI-Public: (01)00801741185380
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/10/2026

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: PWKIT03H
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 02/19/2026
• 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