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	06/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a design defect in the home use purewick system tubing connection, resulted in loss of suction, stagnant fluid accumulation, and recurrent urinary tract infections (utis).A critical quality and design disparity between the purewick system utilized in hospital settings and the version distributed for home care use.""[profanity]"" configuration.The catheter tubing was reported to have securely attached to a robust, ribbed connector that ensures a stable, cohesive seal with the tubing.The home version of external catheters lacked any ribbed or secure locking mechanism, and the connection rapidly degraded.While the manufacturer recommended this tubing every 90 days at a cost of $182 per line, the tubing realistically maintained adequate physical placement for no more than 40 days.This poor connection caused two severe issues: suction failure, where the lack of a cohesive seal drastically limited the system's vacuum/suction capacity and stagnant fluid & infection, where urine failed to clear the line properly due to compromised suction and remained stagnant and festers within the catheter assembly.As a direct consequence of this design flaw and the resulting bacterial exposure, the patient suffered two documented urinary tract infections (utls) within a one year period of use (row-31719-27082026-165640959-1).It was further reported that the home connection mechanism requires an immediate design revision to match the secure, ribbed integration used in clinical settings to prevent patient harm.The most commonly reported problem with the purewick male external catheter home unit is "loss of suction.Based on the reporter's experience, the suction pump/canister unit is not the source of this problem.The point of failure was tubing connector on the external catheter itself, as the home-use catheter uses a flat, unribbed connector at the tubing interface, unlike the purewick ribbed catheters supplied in hospital settings.The home version flat connector did not grip the tubing wall, and a gap open at the seam and causing intermittent times of a loss of suction.Bd/purewick instructed users to replace the collection tubing every 90 days at an approximate cost of $189 per replacement kit.However, the at home unribbed connector did not reliably hold a seal for the full 90-day interval; it began leaking (row-31719-27082026-165640959-2) and losing suction after approximately 45-60 days, roughly half the stated replacement interval.This means the device is being reported and possibly logged as a generic "suction problem" rather than as a connector design/seal defect (row-31719-28082026-052243496-3).Reduced suction leaves urine standing in the catheter, which has contributed to recurrent urinary tract infections during use of the device.A search of the public database shows other reports of leaking and connector related problems with his same product line, which suggesting this may be a broader pattern rather than an isolated incident.
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.

• 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: 50692482
• Report Number: 1018233-2026-05803
• Device Sequence Number: 14925493
• Product Code: NZU
• UDI-Device Identifier: 00801741226465
• 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
• Report Date (Section B): 09/04/2026

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: 08/25/2026
• Initial Report FDA Received Date: 09/09/2026
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 400 LB
• Patient Race: White