MAUDE Adverse Event Report: NOVO HEALTH SERVICES MAJOR SET UP PACK; TRAY, SURGICAL INSTRUMENT

Model Number MINOR SET UP PACK 127879 PRODUCT 5013

Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that during a patient procedure a contrast sticker was found on a carafe.A procedure delay occurred as the sterile field was re-established.The patient was under anesthesia.The staff at novo health services were made aware of the reported event and received training.The inspection policy was reviewed and no changes were required.Product was not sent back to novo.

Event Description

The facility opened the minor set up pack and once they were set up for the procedure the nurse noticed a sticker, which stated "contrast" inside the 900cc carafe.The patient was under anesthesia and a procedure delay occurred as the sterile field was reestablish.

• Brand Name: MAJOR SET UP PACK
• Type of Device: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): NOVO HEALTH SERVICES; 7086 industrial row drive; mason OH 45040
• Manufacturer (Section G): NOVO HEALTH SERVICES
• Manufacturer Contact: rebecca cox ; 7086 industrial row drive; mason, OH 45040
• MDR Report Key: 8395529
• MDR Text Key: 139056676
• Report Number: 1000306225-2018-00006
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MINOR SET UP PACK 127879 PRODUCT 5013
• Device Catalogue Number: 5013
• Device Lot Number: 610942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other