MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL CATHETER

Model Number PW100

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem Urinary Tract Infection (2120)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient was calling to see about possible suggestions to help with the patient having fecal incontinence and it possibly leading to a urinary tract infection or being the cause of a urinary tract infection.It was noted that the patient had been using the purewick products for more than 90 days.It was unknown what medical intervention was provided for the urinary tract infection.

Manufacturer Narrative

Upon further review, bd has determined this event is not reportable.The device was not returned.

Event Description

It was reported that the patient was calling to see about possible suggestions to help with the patient having fecal incontinence and it possibly leading to a urinary tract infection or being the cause of a urinary tract infection.It was noted that the patient had been using the purewick products for more than 90 days.It was unknown what medical intervention was provided for the urinary tract infection.Per additional information received via liberator on 26apr2022, it was stated that the purewick urine collection system was not working and possibly the wicks as well, tried water test with tubing and it suctioned, stopped, same result happened with the wicks almost as if they were intermittently suctioning.It was noted that the patient had been using the purewick products for more than 90 days.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: PUREWICK FEMALE EXTERNAL CATHETER
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14220463
• MDR Text Key: 290175433
• Report Number: 1018233-2022-03066
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• 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: 06/16/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: PW100
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female