MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. CHEST TUBE TRAY; GENERAL SURGERY TRAY

Model Number DYND07603

Device Problems Break (1069); Corroded (1131)

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

Event Date 09/25/2020

Event Type  malfunction  

Event Description

Staff went to open chest tube tray for incoming trauma patient and noted that the scissors had rust on them and that the lidocaine vial had broken and that there was no liquid in the vial or in the tray.Fda safety report id# (b)(4).

• Brand Name: CHEST TUBE TRAY
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60063
• MDR Report Key: 10918997
• MDR Text Key: 218920798
• Report Number: MW5098123
• Device Sequence Number: 1
• Product Code: LRO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/24/2020

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: 08/31/2021
• Device Model Number: DYND07603
• Device Catalogue Number: DYND07603
• Device Lot Number: 202006245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR