MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE DISPOSABLE TUBING, 6FT; CORRUGATED TUBING, PRESSURE AND ACCESSORIES

Model Number HSK626

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  Injury  

Event Description

In opening the post anesthesia car unit for our day's cases, we attach one end of the disposable tubing to the sterile water container for humidification and the other end to a patient mask.When opening the disposable tubing the attached document shows the pieces of tubing falling out of the tubing itself which may have been inhaled by the patient upon coughing.The tubing was immediately discarded and all tubing in the lot number inspected for additional pieces - none were found.A picture was taken of the tubing pieces laid on top of the paper identification for the tubing.

• Brand Name: MEDLINE DISPOSABLE TUBING, 6FT
• Type of Device: CORRUGATED TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 7582138
• MDR Text Key: 110708907
• Report Number: MW5077690
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HSK626
• Device Lot Number: 112917N51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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