MAUDE Adverse Event Report: PRESOURCE / CARDINAL HEALTH BASIC NEURO ORTHO SPINE PK; NEUROLOGICAL TRAY

Catalog Number SNE33BSRHV

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/30/2022

Event Type  malfunction  

Event Description

Improper amount of product.Fda safety report id# (b)(4).

• Brand Name: BASIC NEURO ORTHO SPINE PK
• Type of Device: NEUROLOGICAL TRAY
• Manufacturer (Section D): PRESOURCE / CARDINAL HEALTH; 1500 waukegan rd; waukegan IL 60085
• MDR Report Key: 14311811
• MDR Text Key: 291232265
• Report Number: MW5109566
• Device Sequence Number: 1
• Product Code: OJG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2022

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 Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: SNE33BSRHV
• Device Lot Number: 585398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1