MAUDE Adverse Event Report: DISPO-MED (MALAYSIA) SDN BHD DISPO-MED; T-CONNECTOR

Lot Number 1605005

Device Problem Defective Component (2292)

Patient Problem Respiratory Distress (2045)

Event Date 06/11/2018

Event Type  Injury  

Event Description

Attempting to wean pt off of vent.T-piece placed.Pt began having resp distress.T-piece should be patent - plastic piece (that should have been manufacturing defect) removed during manufacturing was still present, obstructing lumen, and completely obstructing airflow - all except for a pinhole.

• Brand Name: DISPO-MED
• Type of Device: T-CONNECTOR
• Manufacturer (Section D): DISPO-MED (MALAYSIA) SDN BHD; 47810 petaling jaya; selango ; MY
• MDR Report Key: 7600594
• MDR Text Key: 111191700
• Report Number: MW5077847
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Lot Number: 1605005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 44 YR