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

Catalog Number PWF030

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Injury (2348)

Event Date 05/05/2019

Event Type  Injury  

Event 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
• Type of Device: COLLECTOR, URINE, POWERED NON-INDWELLING CATHETER
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 8624867
• MDR Text Key: 145785814
• Report Number: MW5086777
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Catalogue Number: PWF030
• Device Lot Number: MYC20997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 61