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

Model Number PWFX30

Device Problem Malposition of Device (2616)

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

It was reported that the patient did not know how to place purewick female external catheter.Representative recommended troubleshoot and gave basic instructions for placement.Patient was using wick like a tampon.It was noted that the patient had been using the purewick products for more than 90 days.

Manufacturer Narrative

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

Manufacturer Narrative

The reported issue was confirmed as use related issue as per the reported event and ifu.It was unknown whether the device had met specifications.The product was used for treatment purposes.The failure was caused by the misuse of the product.No sample was returned for evaluation.A potential root cause for the issue could be "user unaware of correct use of device, places device incorrectly".The device history record review was not required as the event was confirmed - use related.The instructions for use were found adequate and state the following: "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.Note: patient can be positioned on back, side lying, frog legged, or lying on back with knees bent and thighs apart (lithotomy position) prior to device placement.Never insert the purewicktm female external catheter into vagina, anal canal, or other body cavities".The device was not returned.

Event Description

It was reported that the patient did not know how to place purewick female external catheter.Representative recommended troubleshoot and gave basic instructions for placement.Patient was using wick like a tampon.It was noted that the patient had been using the purewick products for more than 90 days.Per follow-up via phone on 03may2022, it was stated that the patient was still having problems properly placing the purewick female external catheter.Customer have already spoke with liberator on placement techniques which were not working.Representative sent the link to liberator website for placement assistance.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: 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: 14136790
• MDR Text Key: 289467152
• Report Number: 1018233-2022-02654
• 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: 06/23/2022

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: 03/23/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 07/11/2022
• 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