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

Catalog Number	PWF030
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Purewick female external catheter applied to female pt to manage incontinence.Packaging indicates attach to suction at > or = 40 mmhg, with no upper limit indicated.Suction applied at 100 mmgh or more.Pt developed pressure injury.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Common Device Name: COLLECTOR, URINE, POWERED NON-INDWELLING CATHETER
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 8624867
• Report Number: MW5086777
• Device Sequence Number: 1478729
• Product Code: NZU
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2020
• Device Catalogue Number: PWF030
• Device Lot Number: MYC20997
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 61