MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 PureWick Urine Collection System

Catalog Number	PWKIT03
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor stated that where the tubing touches the pt she is getting a reaction that appears to be whelps.Will consult with doctor to see if pt has potential pvc allergy.It's unclear if lot number was requested.Used with female wicks.Unclear if medical intervention was provided.No additional information provided.Per customer, via phone on (b)(6)2026 it was reported, medical treatment done.
Event or Problem Description
It was reported that the doctor stated that where the tubing touches the pt she is getting a reaction that appears to be whelps.Will consult with dr to see if pt has potential pvc allergy.It's unclear if lot number was requested.Used with female wicks.Unclear if medical intervention was provided.No additional information provided.No medical intervention was reported.Per customer, via phone on (b)(6) 2026 it was reported, medical treatment done.
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.Product labeling was reviewed and it states: collector tubing (with elbow connector) and pump tubing initial rinse: disconnect the collector tubing from the elbow connector and disconnect the elbow connector from the lid.Rinse the disconnected tubing thoroughly by running cool tap water through the inside of the tubing.While rinsing, remove any excess dirt by wiping the outside of the tubing and elbow connector with low lint disposable wipes.While rinsing, flush the tubing with cool tap water to remove any excess dirt.Cleaning: prepare a soapy solution by mixing 1 teaspoon (approximately 5 ml) of dish soap with 1 gallon (approximately 4 l) of cool tap water.Completely submerge the tubing and elbow connector in the solution and allow it to soak for a minimum of ten (10) minutes.At the beginning of the soak time, flush the inside of the tubing with the prepared solution.While submerged, use a soft brush (e.G.Toothbrush) to brush all accessible areas of the tubing and elbow connector for a minimum of one (1) minute to remove any visible signs of debris or dirt.Rinse: rinse the tubing and elbow connector thoroughly with cool tap water until there is no visible sign of the soap cleaning solution.While rinsing, flush the inside of the tubing with the tap water.Visual inspection: inspect the tubing to ensure that all debris and dirt have been removed.If there is any sign of debris or dirt, repeat the steps above until there is no sign of debris or dirt remaining on or inside the tubing.Disinfection: fully submerge the tubing and elbow connector in 70 percent isopropyl alcohol (ipa).Allow it to soak for a minimum of ten (10) minutes.Flush the ipa through the tubing, prior to starting the ten (10) minute time.Or prepare a disinfecting solution to yield a 0.1 percent sodium hypochlorite (bleach) solution, using manufacturer's recommendations if applicable.An example dilution for bleach that has a 5.25 percent initial concentration is to dilute 1/3 cup bleach with 1 gallon of cool water to yield a 0.1% sodium hypochlorite (bleach) solution.Fully submerge the tubing and elbow connector in the diluted disinfection solution.Allow it to soak for a minimum of forty five (45) minutes.Flush the diluted disinfection solution through the tubing, prior to starting the forty five (45) minute time.Rinse: rinse the tubing and elbow connector thoroughly with cool tap water, ensuring that the inside of the tubing is flushed with water.Drying: dry the tubing and elbow connector outer surface with a clean low lint towel or cloth and allow the inside of the tubing to air dry for a minimum of thirty (30) minutes at room temperature.A dhr could not be performed since no serial or lot number was provided.No additional actions can be taken at this time.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.
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 Urine Collection System
• 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, GA 30014 ; +1(770)784-6100
• MDR Report Key: 50084489
• Report Number: 1018233-2026-05005
• Device Sequence Number: 13325359
• Product Code: NZU
• UDI-Device Identifier: 00801741185380
• UDI-Public: (01)00801741185380
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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: PWKIT03
• 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: 07/23/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/07/2026
• 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: Female