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

Model Number PWFX30

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

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 issues with placement and was frustrated because the instruction was not clear about how to place the purewick female external catheter.They emailed link to videos and picture of insertion and how the wicks were placed as well as instructions.The patient had been using this product for less than 90 days.Per additional information received from liberator on (b)(6)2023 , stated that the patient had leaking while using purewick female external catheter.The representative went over provide different tips with the patient.It was noted that the patient had been using the purewick products for less than 90 days.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿incorrect / missing translation; missing instructions".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: "recommendations: perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.Prior to connecting the purewicktm female external catheter to hospital wall suction tubing, verify suction function by covering the open end of the suction tubing with one hand and observing the pressure dial.If the pressure does not increase when the line is covered, verify that the tubing is secured, connected, and not kinked.Ensure the purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewicktm female external catheter prior to ambulation.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.Assess device placement and patient¿s skin at least every 2 hours.Replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood.Change suction tubing per hospital protocol or at least every thirty (30) days.Peri-care and placement: 3.Perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.4.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." 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 had issues with placement and was frustrated because the instruction was not clear about how to place the purewick female external catheter.They emailed link to videos and picture of insertion and how the wicks were placed as well as instructions.The patient had been using this product for less than 90 days.Per additional information received from liberator on (b)(6)2023 , stated that the patient had leaking while using purewick female external catheter.The representative went over provide different tips with the patient.It was noted that the patient had been using the purewick products for less 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16492972
• MDR Text Key: 310782036
• Report Number: 1018233-2023-01456
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/13/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/23/2023
• 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): Other
• Patient Sex: Female