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

Model Number PWFX30

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Urinary Tract Infection (2120)

Event Date 05/26/2023

Event Type  Injury  

Event Description

It was reported that the patient kept getting urinary tract infections, but patient was not sure if it was from pure wick female external catheter.Patient was going to talk to doctor.No medical intervention was reported.Per customer via phone on (b)(6) 2023, customer states fecal matter gets into the wick causing an urinary tract infection.Customer states that the rubber needs to be extended to prevent this.Customer states that she does not know if the wick was causing the infections.Customer was treated with antibiotics.Customer also states that there was brown stain that is on the white part of the wick that does not come from her.Per customer via phone on (b)(6) 2023, it was reported that customer spoke with her urologist, and he informed her that she has a urinary tract infection.The doctor prescribed her antibiotics (monural).Customer also stated that the doctor could not determine if the uti came from the purewick catheter or if it came from the customer sitting in urine in her padding.

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 the patient kept getting urinary tract infections, but patient was not sure if it was from pure wick female external catheter.Patient was going to talk to doctor.No medical intervention was reported.Per customer via phone on (b)(6) 2023, customer stated fecal matter gets into the wick caused an urinary tract infection.Customer stated that the rubber needs to be extended to prevent this.Customer states that they did not know if the wick was causing the infections.Customer was treated with antibiotics.Customer also stated that there was brown stain that was on the white part of the wick that did not come from the patient.Per customer via phone on (b)(6) 2023, it was reported that customer spoke with patient's urologist, and doctor informed patient that patient had a urinary tract infection.The doctor prescribed patient antibiotics (monural).Customer also stated that the doctor could not determine if the urinary tract infection came from the purewick catheter or if it came from the customer sitting in urine in patient padding.

Manufacturer Narrative

The reported issue was confirmed as use related issue as per the reported event and ifu.No sample was returned for evaluation.A potential root cause for the issue could be "patient has fecal incontinence and is unaware of their condition or the restrictions of use".A dhr review was not required because the investigation was confirmed - use related.The instructions for use were found adequate and state the following: "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 experiencing skin irritation or breakdown at the site experiencing moderate/heavy menstruation and cannot use a tampon ¿ do not use barrier cream on the perineum when using the purewicktm female external catheter.Barrier cream may impede suction.¿ proceed with caution in patients who have undergone recent surgery of the external urogenital tract.¿ always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.¿ maintain suction until the purewicktm female external catheter is fully removed from the patient to avoid urine backflow.Warnings: "discontinue use if an allergic reaction occurs"."replace the purewicktm 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." "change suction tubing per hospital protocol or at least every thirty (30) days"."perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker." "with soft gauze side facing patient, align distal end of the purewicktm female external catheter at gluteal cleft.Gently tuck soft gauze side between separated gluteus and labia.Ensure that the top of the gauze is aligned with the pubic bone.Slowly place legs back together once the purewicktm female external catheter is positioned." "ensure the purewicktm female external catheter remains in the correct position after turning the patient." "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 may be useful for securing the purewicktm female external catheter for some patients." corrections: a, b, f, h 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: 17349209
• MDR Text Key: 319287054
• Report Number: 1018233-2023-05267
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• 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
• Date Manufacturer Received: 08/29/2023
• 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; Other
• Patient Sex: Female