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

Catalog Number PWFX30

Device Problems Malposition of Device (2616); Device Handling Problem (3265)

Patient Problem Urinary Tract Infection (2120)

Event Date 08/04/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient got urinary tract infections from the purewick female external catheters and was an active sleeper and had dementia.Representative advised if the wicks stay in place, it will prevent urinary tract infections and advised to stop use until infections clear up.It was unknown what medical intervention was provided for urinary tract infections.Per follow up via phone on (b)(6) 2023, it was reported that the customer did not call in to complain.Customer stated that the patient had dementia and had an incontinence and sometimes did not realize that patient had the catheter placed.The customer stated the urinary tract infection was developed from the catheter being moved and patient was on antibiotics and they have put a hold on using the catheters until further notice.Hx- patient had dementia.

Event Description

It was reported that patient got urinary tract infections from the purewick female external catheters and was an active sleeper and had dementia.Representative advised if the wicks stay in place, it would prevent urinary tract infections and advised to stop use until infections clear up.It was unknown what medical intervention was provided for urinary tract infections.Per follow up via phone on 10aug2023, it was reported that the customer did not call in to complain.Customer stated that the patient had dementia and had an incontinence and sometimes did not realize that patient had the catheter placed.The customer stated the urinary tract infection was developed from the catheter being moved and patient was on antibiotics and they have put a hold on using the catheters until further notice.

Manufacturer Narrative

The reported issue was confirmed as use related issue as per the reported event and ifu.A potential root cause for this failure could be "healthcare professional (or caregiver) accidentally jostles patient or forgets the patient is using the device".A dhr review was not required because the investigation was confirmed as use related.The instructions for use were found adequate and state the following: "precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter.Having frequent episodes of bowel incontinence without a fecal management system in place.Warnings: "to avoid potential skin injury, never push or pull the purewicktm female external catheter against the skin during placement or removal." recommendations: properly placing the purewicktm female external catheter snugly between the labia and gluteus holds the purewicktm female external catheter in place for most patients.Mesh underwear maybe useful for securing the purewicktm female external catheter for some patients.Assess device placement and patient¿s skin at least every 2 hours." 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 device was not returned.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17669411
• MDR Text Key: 322477062
• Report Number: 1018233-2023-06475
• 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: 10/13/2023

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 Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 10/14/2023
• Supplement Dates FDA Received: 10/16/2023
• 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