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

Model Number PWFX30

Device Problem Device Handling Problem (3265)

Patient Problems Urinary Tract Infection (2120); Fecal Incontinence (4571)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had started getting urinary tract infections.The patient had discontinued use of the purewick female external catheter for now.The liberator representative suggested speaking with a doctor.It was noted that the patient had been using this product for less than 90 days.It was unknown what medical intervention was provided for urinary tract infection.Per follow up received via phone on (b)(6) 2022, it was stated that patient had been hospitalized 7 times with urinary tract infections.It was stated that the patient had bowel incontinence and was prescribed antibiotics for 5 days, but the doctor discontinued the antibiotics because they do not want patient to become resistant and currently has 3 bladder infections.

Manufacturer Narrative

The reported event was confirmed use related as the reported event stated " the patient had incontinence bowel and bladder".A potential root cause for this failure could be due to "patient has fecal incontinence or is menstruating and is unaware of their condition or the restrictions of use.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warnings: discontinue use if an allergic reaction occurs.Not recommended for patients who are: -agitated, combative, or uncooperative and might remove the purewick¿ female external catheter -having frequent episodes of bowel incontinence without a fecal management system in place.Recommendations: ¿ replace the purewick¿ female external catheter every 8-12 hours or when soiled with feces or blood.¿assess device placement and patient¿s skin at least every 2 hours." 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.H3 other text : the device was not returned.

Event Description

It was reported that the patient had started getting urinary tract infections.The patient had discontinued use of the purewick female external catheter for now.The liberator representative suggested speaking with a doctor.It was noted that the patient had been using this product for less than 90 days.It was unknown what medical intervention was provided for urinary tract infection.Per follow up received via phone on (b)(6)2022, it was stated that patient had been hospitalized 7 times with urinary tract infections.It was stated that the patient had bowel incontinence and was prescribed antibiotics for 5 days, but the doctor discontinued the antibiotics because they do not want patient to become resistant and currently has 3 bladder infections.

• 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: 15700202
• MDR Text Key: 302706729
• Report Number: 1018233-2022-08227
• 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: 12/12/2022

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: 10/17/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 12/13/2022
• 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