MAUDE Adverse Event Report: BD/ C.R BARD PUREWICK FEMALE EXTERNAL CATHETER; COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER

Model Number PWF030

Device Problems Leak/Splash (1354); Use of Device Problem (1670)

Patient Problems Skin Erosion (2075); Fungal Infection (2419); Localized Skin Lesion (4542)

Event Date 01/08/2021

Event Type  Injury  

Event Description

Please re-evaluate purewick female external catheters and consider limiting it to single use only and to be changed shortly after use, or in the case of leak incontinence, after becoming notably wet.Two purewick external female catheters were left in place twice for roughly 2-3 hours each time and repeatedly use for urination on (b)(6) 2021.Where its sponge made contact, the purewick caused skin breakdown on the labia and a skin lesion on a postpartum labial scar.An infection, maybe yeast, later set in where the skin broke down.Currently, the directions for purewick state it's to be changed every 8 hours.The nursing staff said it was good for repeated use over that time.Since suction dries urine in the sponge, repeated use may be causing uric acid to become more concentrated in each use and may be accelerating skin break down.Urine isn't sterile, pathogens may be accumulating on its surface.Fda safety report id # (b)(4).

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER
• Manufacturer (Section D): BD/ C.R BARD
• MDR Report Key: 11207585
• MDR Text Key: 228606052
• Report Number: MW5098933
• Device Sequence Number: 2
• Product Code: NZU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/18/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PWF030
• Device Catalogue Number: PWF030
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 47 YR
• Patient Weight: 52