MAUDE Adverse Event Report: C. R. BARD, INC. NOVAPLUS CWS 400 CLOSED WOUND SUCTION KIT; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Lot Number NGEV2326

Device Problems Dull, Blunt (2407); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2021

Event Type  malfunction  

Event Description

Surgeon was wanting to place a drain in the surgical wound area.As he was attempting to pierce the skin using the trocar provided in the kit, it was dull and would not go through the skin.Excessive force was needed.

• Brand Name: NOVAPLUS CWS 400 CLOSED WOUND SUCTION KIT
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11526382
• MDR Text Key: 241008516
• Report Number: 11526382
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2021,03/16/2021

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 Lot Number: NGEV2326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 78