MAUDE Adverse Event Report: NEWGEN SURGICAL NEWGEN SURGICAL NEEDLE COUNTER; CONTAINER, SHARPS

Catalog Number NGSMN40FMA

Device Problems Product Quality Problem (1506); Structural Problem (2506)

Patient Problems Exposure to Body Fluids (1745); Laceration(s) (1946)

Event Date 09/17/2018

Event Type  malfunction  

Event Description

Scalpel went through sharps container and into left index finger.Sharps container by newgen is not a hard type container and allowed scalpel to penetrate container.

• Brand Name: NEWGEN SURGICAL NEEDLE COUNTER
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): NEWGEN SURGICAL; 41 simms st, suite b; san rafael CA 94901
• MDR Report Key: 7933375
• MDR Text Key: 122671012
• Report Number: 7933375
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00864887000047
• UDI-Public: (01)00864887000047
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NGSMN40FMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2018
• Date Report to Manufacturer: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other