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

Model Number PWF030

Device Problem Positioning Problem (3009)

Patient Problem Ulcer (2274)

Event Date 12/14/2020

Event Type  malfunction  

Event Description

Primary nurse identified a wound on patient¿s coccyx following transfer to unit this morning from cardiac unit.Patient reports previously having a purewick.Review of record shows a purewick was in place while patient was on cardiac unit.Wound rn assessed patient and identified: labia (vulva) pressure related pi from purewick, unable to stage due to mucosal membrane, apply soothe and cool.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11071862
• MDR Text Key: 223611702
• Report Number: 11071862
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PWF030
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29200 DA
• Patient Weight: 70