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

Model Number PWFX30

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/29/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the purewick female external catheter was painful and tried wearing it 3 different times and it was very painful during insertion.There were no instructions on the plug part of the system and it was not one size fits at all and never able to drain.No medical intervention was reported.Per follow-up via phone on (b)(6) 2022, it was reported that the customer was not interested in any further troubleshooting and wanted to speak with liberator about refund options.Per additional information received via liberator on (b)(6) 2022, customer tried using three of the wicks but could not use them because they were very uncomfortable and painful.Lms representative attempted to obtain additional information, but the customer declined to provide any further details and they just wanted a refund.Lms representative offered to conduct troubleshooting and discuss wick prep and placement but the customer was not interested in any further troubleshooting.No medical intervention was reported.

Manufacturer Narrative

The reported issue was confirmed as use related issue as per the reported event and instruction for use.A potential root cause for this failure could be "user unaware of correct use of device, places device incorrectly".A device history record review was not required as the event was 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.Under warnings it states "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 purewick female external catheter was painful and tried wearing it 3 different times and it was very painful during insertion.There were no instructions on the plug part of the system and it was not one size fits at all and never able to drain.No medical intervention was reported.Per follow-up via phone on 01aug2022, it was reported that the customer was not interested in any further troubleshooting and wanted to speak with liberator about refund options.Per additional information received via liberator on 02aug2022, customer tried using three of the wicks but could not use them because they were very uncomfortable and painful.Lms representative attempted to obtain additional information, but the customer declined to provide any further details and they just wanted a refund.Lms representative offered to conduct troubleshooting and discuss wick prep and placement but the customer was not interested in any further troubleshooting.No medical intervention was reported.

• 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: 15210051
• MDR Text Key: 305138933
• Report Number: 1018233-2022-06301
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• 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
• Date Manufacturer Received: 11/17/2022
• 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