MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH, SU, SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 135150

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.A follow up report will be sent at the the conclusion of the investigation.

Event Description

Customer complaint alleges "when the staff tried to insert the tube in the mask (size 5), the tube got stuck on the mask.The staff tried with a mask size 4, and the intubation was performed properly." customer reported a delay in intubation.There was no report of patient injury or complication.The patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer complaint alleges "when the staff tried to insert the tube in the mask (size 5), the tube got stuck on the mask.The staff tried with a mask size 4, and the intubation was performed properly." customer reported a delay in intubation.There was no report of patient injury or complication.The patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer complaint alleges "when the staff tried to insert the tube in the mask (size 5), the tube got stuck on the mask.The staff tried with a mask size 4, and the intubation was performed properly." customer reported a delay in intubation.There was no report of patient injury or complication.The patient condition was reported as "fine".

• Brand Name: LMA FASTRACH, SU, SIZE 5
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 7628613
• MDR Text Key: 111986292
• Report Number: 9681900-2018-00030
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

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: No Information
• Device Expiration Date: 03/28/2019
• Device Catalogue Number: 135150
• Device Lot Number: LPAAQD
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 07/04/2018
• Supplement Dates FDA Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FASTRACH ETT 136080; FASTRACH ETT 136080; FASTRACH ETT 136080