MAUDE Adverse Event Report: STRADIS HEALTHCARE CENTRAL LINE KIT; GENERAL SURGERY TRAY

Lot Number 211112719

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2022

Event Type  malfunction  

Event Description

Central line kits are missing claves.Multiple kits have been identified and pulled from circulation.

• Brand Name: CENTRAL LINE KIT
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): STRADIS HEALTHCARE; 3025 northwoods pkwy; peachtree corners GA 30071
• MDR Report Key: 13860476
• MDR Text Key: 287673744
• Report Number: 13860476
• Device Sequence Number: 1
• Product Code: LRO
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 211112719
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1