MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; NEUROLOGICAL TRAY

Model Number PN11CLFHD

Device Problem Contamination (1120)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

When opening for a laminectomy, the scrub tech noticed a hair in the laminectomy/discectomy pack.The pack and soft goods were discarded and a new one was obtained.Pack info: brand: presource pbds.Cat# (b)(4).Lot# 835498.

• Brand Name: CARDINAL HEALTH
• Type of Device: NEUROLOGICAL TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15275221
• MDR Text Key: 298406969
• Report Number: 15275221
• Device Sequence Number: 1
• Product Code: OJG
• 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: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PN11CLFHD
• Device Catalogue Number: PN11CLFHD
• Device Lot Number: 835498
• 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: 08/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Female