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

Model Number	66-1991
Medical Device Problem Codes	Disconnection (1171); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8597252
• Report Number: 3012307300-2019-02544
• Device Sequence Number: 14001288
• Product Code: BZA
• UDI-Device Identifier: 10788942619913
• UDI-Public: 10788942619913
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: 107889426199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1