MAUDE Adverse Event Report: COVIDIEN LP VALLEYLAB SMOKE EVACUATION PENCIL CONTAINER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number CVPLP2000

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2020

Event Type  malfunction  

Event Description

Smoke evacuation pencil container seal is not able to be opened without contaminating the item inside due to package not sealing when you pull the paper cover off.Manufacturer response for valleylab smoke evacuation pencil container, valleylab smoke evacuation pencil container (per site reporter).Manufacturer is providing 100% reimbursement for the defect packaging.

• Brand Name: VALLEYLAB SMOKE EVACUATION PENCIL CONTAINER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10118292
• MDR Text Key: 193948484
• Report Number: 10118292
• Device Sequence Number: 1
• Product Code: GEI
• 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: 05/05/2020,04/30/2019

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: No Information
• Device Model Number: CVPLP2000
• Device Catalogue Number: CVPLP2000
• Device Lot Number: 190906204X
• 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: 05/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2020
• Type of Device Usage: N
• Patient Sequence Number: 1