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

Catalog Number	PWM030
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Skin Discoloration (2074); Blister (4537); Unspecified Tissue Injury (4559)
Date of Event	06/02/2025
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 patients were experiencing redness, blisters and injuries due to suction issue of purewick male external catheter.
Event or Problem Description
It was reported that purewick external urine management device product information states to attach to suction at >40 mm hg and it did not give a high end to stop.The suction setting in the hospital setting can go to 200 mm hg.They have noted increased reports of redness, blisters and injuries to male patients in the setting.
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.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: instructions for use setup: 1.Connect a canister to wall suction and set to a minimum of 40mmhg continuous suction.Always use the minimum amount of suction necessary.2.Using standard suction tubing, connect the device to a collection canister.Note: collection canister and suction tubing are not included.If hospital policy allows and if using a graduated canister, captured urine may be used for approximate urine output measurement.Peri-care and placement: 3.If there is significant pubic hair, trim or clip the pubic hair.Perform perineal care using the included wipes and assess skin integrity.Follow and document per hospital protocol.Note: use the included drying wipe to ensure skin is dry prior to placement of the device.Moisture on skin will weaken the adhesive.4.Orient the device, aligning drainage fitting towards the feet of the patient.Slide the opening of the device over the penis until close to the pelvic skin.Center penis within the opening.Remove adhesive liner and press the device against the pelvic skin to adhere.Ensure base has fully adhered around the base of the penis.Note: the scrotum should not be placed inside the device.Removal: 5.To remove the device, gently lift the top edge of the device off the skin.In a slow, downward peeling motion, remove the device.If necessary, use a warm wet compress (such as a wet washcloth) to help loosen adhesive.Warning: to avoid potential skin injury, never pull the device directly away from the patient.Always peel in the direction from head to foot.Maintenance: 6.Replace the device at least every 24 hours or if soiled with feces, blood, or semen.Correction: b, d, f, 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.

• Brand Name: PUREWICK MALE EXTERNAL CATHETER KIT
• Common Device Name: PUREWICK 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: 22374019
• Report Number: 1018233-2025-05344
• Device Sequence Number: 15433511
• Product Code: NZU
• UDI-Device Identifier: 00801741219153
• UDI-Public: (01)00801741219153(11)241101(17)260930(10)NGJX1850
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: PWM030
• Device Lot Number: NGJX1850
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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