MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 30-CE8SF

Device Problems Break (1069); Crack (1135); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  malfunction  

Event Description

Opened a cardinal thoracentesis tray and there were two broken, empty glass vials of lidocaine inside.The vials had no packing material around them to keep them secure in the tray.They were loose in the tray and the glass cracked/broke.This could have been prevented if the glass vials were packaged more securely within the tray.We have had other cardinal thoracentesis trays where this has happened before.

• Brand Name: CARDINAL HEALTH
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12567912
• MDR Text Key: 274528314
• Report Number: 12567912
• Device Sequence Number: 1
• Product Code: GCX
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 30-CE8SF
• Device Catalogue Number: 30-CE8SF
• 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: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1