MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM

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	01/21/2026
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 caregiver states the patient issue; longer tube, worry about suction, cb set for (b)(6) 2026 @ 10am.Used with male wicks.No additional information provided.\ it's unclear if troubleshooting was provided.(prepping and placement tips shared) per (b)(6), via phone on (b)(6) 2026 it was reported, no t/s done.
Event or Problem Description
It was reported that the caregiver states the patient issue; longer tube, worry about suction, call back set for 17jan2026 at 10am.Used with male wicks.No additional information provided.It's unclear if troubleshooting was provided.Prepping and placement tips shared.Via phone on 27jan2026 it was reported, no troubleshooting was done.
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: initial setup: 3.Place the purewick urine collection system (a) next to the bed or chair where it will be used.It must be close enough for the collector tubing with elbow connector (g) to easily reach the user and should be placed on a stable, even surface.For optimal results, position the purewick urine collection system either on the floor or as close to the floor as your facility¿s protocol will allow.Note: the purewick urine collection system should be stationary while in use.Device is not designed to be used while in transport.Caution: avoid creating a tripping hazard with the collector tubing or power cord.4.Plug the purewick urine collection system power cord into device outlet (b) and into an ac power outlet.Note: the device should be positioned for easy access to the ac inlet and power cord.Note: make sure the power switch is turned off before connecting the power cord.5.Place the collection canister (c) in the purewick urine collection system base and press down firmly on the lid making sure the lid is sealed.Attach the pump tubing (d) to the purewick urine collection system connector port (f) and the connector port (e) on the collection canister lid.6.Attach the collector tubing (g) to the connector port (h) on the collection canister lid.Caution: it is important that the port connections be connected correctly and securely for proper operation of the purewick urine collection system.7.Turn on the purewick urine collection system by pressing the on off switch.The purewick urine collection system is working when the switch lights up green and the device makes a soft humming sound.8.Connect the other end of the collector tubing securely to a purewick external catheter (i).The system is now ready for use.Troubleshooting: 1.Ensure tubing connections are connected properly.2.Check collector tubing for blockage or flow restriction such as pinched or kinked tubing.3.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.4.Ensure collection canister is sealed with the lid tightly closed.5.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.A dhr could not be performed since no lot number was provided.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.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM
• 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: 24228772
• Report Number: 1018233-2026-00531
• Device Sequence Number: 10269748
• Product Code: NZU
• UDI-Device Identifier: 00801741185380
• UDI-Public: (01)00801741185380
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/02/2026

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
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/05/2026
• 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: Male