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

Catalog Number	PWKIT03
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the customer said the hose does not stay connected to the wick causing tons of leakage and sores from urine sitting.It is unclear if troubleshooting was performed.It is unknown if lot/serial number was requested.Used with female wicks.No medical intervention was reported.
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.
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 state: initial setup: inspect the package for damage.Carefully remove all contents from the package, including the packing material and inspect prior to use.If any damage is noticed, contact customer support at immediately.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.Optional (prior to sealing canister lid): while operating the purewick¿ urine collection system, ammonia odor for up to 1800 ml of urine can be eliminated by adding 2 teaspoons (10 grams) of vitamin c (ascorbic acid) powder into the collection canister before use.At least 99.93% of pure vitamin c (ascorbic acid) is recommended.If using the privacy cover (j), slip privacy cover onto canister (similar to a coffee cup sleeve) prior to placing canister into the base.Attach the pump tubing (d) to the purewick¿ urine collection system connector port (f) and the connector port (e) on the collection canister lid.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.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.Connect the other end of the collector tubing securely to a purewick¿ external catheter (i).The system is now ready for use.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.Replacing canister and tubing: replace the canister and tubing for each patient according to useful life: every 60 days for pwkit03 canister and accessories (this kit includes a canister without handle).If you notice any of the following, replace immediately: canister or tubing has residual urine build-up; canister or tubing appear cloudy; canister or tubing appear discolored; canister becomes cracked; tubing becomes torn.The dhr review could not be performed without a lot number.No additional actions can be taken at this time.Correction: b, d.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 said the hose does not stay connected to the wick causing tons of leakage and sores from urine sitting.It is unclear if troubleshooting was performed.It is unknown if lot/serial number was requested.Used with female wicks.No medical intervention was reported.

• 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 ; 7707846100
• MDR Report Key: 24032142
• Report Number: 1018233-2025-11683
• Device Sequence Number: 18456615
• 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): 01/27/2026

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: 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Female