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

Model Number PWF030

Device Problem Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Event Description

While rn was setting up a brand new purewick, it was noted the purewick didn't appear to be suctioning as normal.Another purewick was obtained and worked just fine.Manufacturer response for female external catheter, purewick female external catheter (per site reporter).Equipment failure reported to manufacturer's customer care team.No response as of today.Equipment is available for return to manufacturer.

• 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: 16101687
• MDR Text Key: 306696898
• Report Number: 16101687
• 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: 12/29/2022,12/22/2022

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 Model Number: PWF030
• Device Catalogue Number: PWF030
• Device Lot Number: MYG2275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1