MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS; CONNECTOR, AIRWAY (EXTENSION)

Model Number 66-1991

Device Problems Disconnection (1171); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2019

Event Type  Injury  

Event Description

It was reported that during a bronchoscopy procedure, the blue top of the elbow separated from the elbow.When the separation occurred it caused the et tube to be pulled out of the patient.An urgent re-intubation of a new et tube was performed without any complications.The patient was reported to be doing well after this intervention was taken.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a bronchoscopy procedure, the blue top of the elbow separated from the elbow.When the separation occurred it caused the et tube to be pulled out of the patient.An urgent re-intubation of a new et tube was performed without any complications.The patient was reported to be doing well after this intervention was taken.It was further reported that after further discussions with the respiratory techs, the reporter believed that the issues could have been attributed to user error.The reporter stated that a therapeutic bronchoscopy scope was used in a small trach, and when it became lodged in the trach, everything came apart".

• Brand Name: PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8597252
• MDR Text Key: 144616177
• Report Number: 3012307300-2019-02544
• Device Sequence Number: 1
• Product Code: BZA
• UDI-Device Identifier: 10788942619913
• UDI-Public: 10788942619913
• Combination Product (y/n): N
• PMA/PMN Number: 107889426199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2023
• Device Model Number: 66-1991
• Device Catalogue Number: 66-1991
• Device Lot Number: 3671388
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1