MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 PUREWICK MALE EXTERNAL CATHETER

Catalog Number	PWMX30
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	04/09/2026
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
Pt stated that it is not the pump that is bad it is the pouches, she used an old pouch and the pouch worked fine but the new cs she received is bad and not abler to suction the urine.Unclear if medical intervention was provided.No additional information provided.Per customer via email on (b)(6) 2026, there was impact to the patient.Patient got a urinary tract infection because of nightly leaking from the faulty wicks and is now being hospitalized due to said infection.There are unused wicks available but not used ones.Before any other changes were made to system, wicks from a different lot were used which resolved the leaking.It was unknown what medical intervention was provided for urinary tract infection.
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.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it state: warnings: do not use on irritated skin.Examples include, but are not limited to, rashes, skin tears, or blisters.Precautions: do not use barrier creams, lotions, or ointments on the penis or pubic skin around the base of the penis when using the device.These may impede suction or weaken adhesive.Recommendations: wash hands thoroughly before device placement.Ensure the device remains connected after turning the user, monitoring for pulling and tension on the device.Remove the device prior to walking.Check device placement and user¿s skin at least every 2 hours.Placement of purewicktm male external catheter: trim or clip the pubic hair to ensure the product securely adheres to the skin.Check the skin and do not use if there is irritation or breakdown.Clean the penis and the skin around the base of the penis with soap and water or soap and water wipes.Dry skin prior to positioning the device.Note: moisture or soap residue on skin will weaken the adhesive.Position the device, aligning drainage fitting towards the feet of the user.Slide the opening of the device over the penis until close to, but not touching, the skin around the base of the penis.Center penis within the opening.Do not place scrotum inside the device.Remove the bottom adhesive peeloff and press the device against the skin below the base of the penis.Remove the top adhesive peeloff and press the device against the skin above the base of the penis.Ensure device has fully adhered around the base of the penis by pressing down on the adhesive.When to replace purewicktm male external catheter: replace the device at least every 24 hours or if soiled with feces, blood, or semen.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: d, h.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
Pt stated that it is not the pump that is bad it is the pouches, she used an old pouch and the pouch worked fine but the new cs she received is bad and not abler to suction the urine.Unclear if medical intervention was provided.No additional information provided.Per customer via email on 09apr2026, there was impact to the patient.Patient got a urinary tract infection because of nightly leaking from the faulty wicks and is now being hospitalized due to said infection.There are unused wicks available but not used ones.Before any other changes were made to system, wicks from a different lot were used which resolved the leaking.It was unknown what medical intervention was provided for urinary tract infection.

• Brand Name: PUREWICK MALE EXTERNAL CATHETER
• Common Device Name: MALE EXTERNAL 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 ; 7707846100
• MDR Report Key: 24879610
• Report Number: 1018233-2026-02484
• Device Sequence Number: 9099845
• Product Code: NZU
• UDI-Device Identifier: 00801741226465
• UDI-Public: (01)00801741226465(11)250801(17)270531(10)NGKT3196
• 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): 04/29/2026

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: PWMX30
• Device Lot Number: NGKT3196
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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