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

Model Number PWFX30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Urinary Tract Infection (2120)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported that the patient kept getting urinary tract infection because of purewick female external catheter.Patient had been using the purewick product for more than 90 days.It was unknown what medical intervention was provided for urinary tract infection.Per customer via phone on (b)(6) 2022, it was reported that the customer experienced multiple urinary tract infections since using the purewick female external catheter.Customer stated that they were in the hospital for 4 days with sepsis from the urinary tract infection.Customer stated they did not have a history of urinary tract infections prior to using the purewick.Customer stated they had been prescribed several antibiotics and had been on antibiotics for over the last month.Customer stated they saw their urologist regularly and will follow their urologists orders if they told them to stop using the purewick.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "inadequate material selection - materials of construction are not biocompatible or material surface is rough, abrasive or uncomfortable".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: " discontinue use if an allergic reaction occurs.Replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.Assess device placement and patient¿s skin at least every 2 hours.Not recommended for patients who are: experiencing skin irritation or breakdown at the site".H11: section a through f - the information provided by bard represents all of 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 bard.

Event Description

It was reported that the patient kept getting urinary tract infection because of purewick female external catheter.Patient had been using the purewick product for more than 90 days.It was unknown what medical intervention was provided for urinary tract infection.Per customer via phone on (b)(6) 2022, it was reported that the customer experienced multiple urinary tract infections since using the purewick female external catheter.Customer stated that they were in the hospital for 4 days with sepsis from the urinary tract infection.Customer stated they did not have a history of urinary tract infections prior to using the purewick.Customer stated they had been prescribed several antibiotics and had been on antibiotics for over the last month.Customer stated they saw their urologist regularly and will follow their urologists orders if they told them to stop using the purewick.

• 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: 15220221
• MDR Text Key: 297824624
• Report Number: 1018233-2022-06346
• 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: 10/14/2022

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: PWFX30
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 10/15/2022
• Supplement Dates FDA Received: 10/19/2022
• 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): Required Intervention
• Patient Sex: Female