MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM

Model Number PW200

Device Problem Intermittent Loss of Power (4016)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/21/2022

Event Type  Injury  

Event Description

It was reported that the purewick urine collection system cuts on and off, which caused the customer to have urine all over.Also stated that the motor has no sound when it randomly cuts off.And the machine passed water test.Representative advised customer to replace kit every 60 days, but the customer was unsatisfied about the purewick urine collection system and said sometimes it works and sometimes it doesn't work.It was noted that the patient had been using the purewick products for less than 90 days.Per additional information received via form with sample returned on 18jan2023, the unit worked well when in use, but after about 2 months, the unit started to shut off inadvertently, which was not noticed until the bed pad kept getting wet.After watching it for a while, they saw that it would shut off for sometime and then turn back on.However, the green light stayed on and the humming noise remained constant until it went off.When the unit stopped or shut off inadvertently, it would not catch the urine, thus leaving the bed pads and linens completely wet.Patient experienced not much but skin would break because of urine on skin too long and used medication cream for skin irritation and protection.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.A bd purewick urine collection system, pump tubing, collector tubing with elbow connector, and a collection canister with lid were returned.An in-house external power cord was used for testing.There were no cracks present.There was no residue present.The stop valve was working properly.There was light and sound indicating function.The device was left on for 5 to 10 minutes to gauge system failure and the device remained on successfully.The device passed with a value of 2.228 slpm.Once the system was powered on and ran for 30 seconds, the device passed a 500g increase in 16.92 seconds.No root cause could be found because the reported event was unconfirmed.A dhr review was not required as the investigation was unconfirmed.As the reported event is unconfirmed a labeling review is not required.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.H3 other text: the actual/suspected device was inspected.

Event Description

It was reported that the purewick urine collection system cuts on and off, which caused the customer to have urine all over.Also stated that the motor has no sound when it randomly cuts off.And the machine passed water test.Representative advised customer to replace kit every 60 days, but the customer was unsatisfied about the purewick urine collection system and said sometimes it works and sometimes it doesn't work.It was noted that the patient had been using the purewick products for less than 90 days.Per additional information received via form with sample returned on 18jan2023, the unit worked well when in use, but after about 2 months, the unit started to shut off inadvertently, which was not noticed until the bed pad kept getting wet.After watching it for a while, they saw that it would shut off for sometime and then turn back on.However, the green light stayed on and the humming noise remained constant until it went off.When the unit stopped or shut off inadvertently, it would not catch the urine, thus leaving the bed pads and linens completely wet.Patient experienced not much but skin would break because of urine on skin too long and used medication cream for skin irritation and protection.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM
• Type of Device: PUREWICK URINE COLLECTION SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16291275
• MDR Text Key: 308714556
• Report Number: 1018233-2023-00575
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185359
• UDI-Public: (01)00801741185359
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/05/2023
• Device Model Number: PW200
• Device Catalogue Number: PW200
• Device Lot Number: BMFXPX19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female