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

Catalog Number	PW300
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
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 pure wick 300 caused bleeding.The patient had to go to the emergency room.The patient's husband said this unit is dangerous and asked for a refund.Used with female wicks.No additional information provided.No troubleshooting was provided.It was unknown what medical intervention was provided.
Additional Manufacturer Narrative
The initial reporter's zip code: (b)(6).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: use related warnings: note: do not use purewick portable collection system while driving a vehicle or operating heavy machinery.Discontinue use if an allergic reaction occurs.Not recommended for users who are experiencing skin irritation or skin breakdown in device contact areas.It is important that the port connections be connected correctly, and the lid pressed down securely for proper operation of the purewick portable collection system.Incorrect or inadequately secured connections can result in loss of suction.The lot file was not available at the time of the investigation closure; therefore, dhr could not be reviewed.No additional actions can be taken at this time.Correction: a, b.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 purewick 300 caused bleeding.The patient had to go to the emergency room.The patient's husband said this unit is dangerous and asked for a refund.Used with female wicks.No additional information provided.No troubleshooting was provided.It was unknown what medical intervention was provided.

• 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: 24378844
• Report Number: 1018233-2026-00911
• Device Sequence Number: 18706564
• Product Code: NZU
• UDI-Device Identifier: 00801741231001
• UDI-Public: (01)00801741231001
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/25/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: PW300
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/25/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female