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

Catalog Number	PWMX30
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the attorney-in-fact for a patient/caregiver who uses the male bard external catheters at home, supplied through liberator medical supplies.Product name, catalog number, serial number: bd purewick portable collection system; pw300; dykxst0709.Customer have seen that the tubing connector on the home-use catheters was flat/smooth, in contrast to the ribbed connector used on catheters customer have received during hospital stays.In practical use, this difference has resulted in an inconsistent seal between the catheter and collection tubing, intermittent leaking at the connection point, and reduced suction.Urine has been left standing in the catheter as a result, and they have experienced recurrent urinary tract infections that they believe are connected to this connection failure.It was unknown what medical intervention was provided for urinary tract infection.
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 Catheter
• Common Device Name: Purewick
• 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 30014 ; +1(770)784-6100
• MDR Report Key: 50718392
• Report Number: 1018233-2026-05849
• Device Sequence Number: 9779249
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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?: No
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/10/2026
• 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