MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 PureWick¿Male External Catheters; PureWick Male Catheter

Catalog Number	PWMX30
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that her son's pw was not functioning properly.She stated the urine was sitting in the catheter portion and was not suctioning away.She was worried this would cause a uti.She was also concerned with how many mecs she was going through because she had been replacing it every time, he urinated so he wasn't sitting in it.No medical intervention was reported.Discussed further with patient.She believes he is sitting in the urine as the gauze is slightly tinted yellow, meaning it is wet still.Confirmed there is no urine pooled in the bottom of the mec, just the color changed gauze.Discussed how it is possible that the urine may stain the gauze giving the appearance of still being wet.The purewick male external catheter wicking material dries within 25 minutes leaving no residual urine.Discussed proper placement and confirmed no lotions and ointments are being used.Inquirer spoke to a bd rep yesterday and placed the tubing in a cup of water to which it suctioned away fine.This rep (no case found in the system from medical information team).Told inquirer she can try the female purewick if male purewick isn't working.Explained the female purewick is only indicated for females.
Additional Manufacturer Narrative
The investigation did not reveal any additional findings as the sample was not available to allow for further evaluation.Our team conducted a review of the reported event using all available information to ensure the continued safety and performance of the product.The investigation has been completed and determined that this issue represents a known failure mode, which has been previously assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be actively monitored as part of our ongoing post market surveillance activities in compliance with regulatory requirements and company procedures.Based on the results of the investigation, no further action is required at this time.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.

• Brand Name: PureWick¿Male External Catheters
• Common Device Name: PureWick Male Catheter
• 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: 50397075
• Report Number: 1018233-2026-05530
• Device Sequence Number: 13064764
• Product Code: NZU
• UDI-Device Identifier: 00801741226465
• UDI-Public: (01)00801741226465
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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: PWMX30
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/23/2026
• Supplement Report FDA Received Date: 08/27/2026
• 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