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	06/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pt said my machine rattles and causes condensation from the wick and it gurgles a lot this should be fixed is my suggestion.Used with male wicks.Unclear if medical intervention was provided.No additional information provided.As per customer follow up information received via email on 26jun2026, i was calling because the machine seems to gurgle urine all night.It also leaves condensation under the bag between the bag and body because of some urine sitting in the bag.It¿s not a lot.It¿s a very small amount here and there but enough to be gurgling all night and leave the condensation.I have since realized this is because the suction is not quite strong enough.It shouldn¿t gurgle trying to get all the urine up all night long and if it was clearing the bag, it wouldn¿t have condensation.Like i said, i¿ve used other machines before and your bags without this issue.I really think the new machine needs a slightly stronger suction.I was very disappointed when the nurse service member told me on the phone the rattling of the lid was the problem and it rattles when it gets wet.So that¿s why it¿s gurgling.I knew this was not the case because, i ordered an extra canister that had not even been used, and it rattled.The rattle is not an issue and is part of the design.I don¿t believe it impacts the device at all, and they came up with this somehow.Despite it not being clear in directions or in the how to clean in regard to the filter, videos that i recall from using other devices i know you shouldn¿t get the filter wet.I specifically do not submerge the lid, drip water into the area sounding the filter without getting water into it and even am able to let the enzyme cleaner sit in those spots and rinse carefully without getting water into the filter.I have this down.Last, i can put these bags on with my eyes closed.Just to ensure you there isn¿t user error.I¿ve don¿t this for a while now.I do want to point out which further supports the lack of suction theory something i experimented with.I ordered an of brand of bag (external catheter) that is frequently to advertised on social.I decided to do a comparison on bags and ordered the generic on amazon as well.So now i have the three bags.The amazon was equal to you.The other brand name was superior, and it solved the condensation and gurgling.I believe the reason for this is that the other name brand bag is slightly smaller and creates more suction.You can see the difference even when it¿s on the patient and machine is turned on.I have zero issues with it.I¿m telling you this because you guys are the og.I believe you can make an easy tweak to take care of this issue.As i said before, i can¿t live without it! it¿s been a game changer.I can¿t wait to travel our first flight with it! i really hope pure wick is able to navigate this small tweak to continue to dominate and lead in the external catheter industry.I don¿t know what a product catalog number is.I bought the portable system as a package.When i called that something was wrong, she offered to send me a new machine thinking my current had some malfunction.They work the same.No malfunction, more of a slight design error.
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: 50734679
• Report Number: 1018233-2026-05866
• Device Sequence Number: 21476440
• Product Code: NZU
• UDI-Device Identifier: 00801741226465
• UDI-Public: (01)00801741226465
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/15/2026

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
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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