MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA GASTRO CUFF PILOT SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 1E5040

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

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.The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges "lma gastro was inserted into patient.The cuff pilot was in the red and the cuff was clearly overinflated.The clinician tried to take air out of the cuff, and it couldn't be done.The syringe wasn't engaging properly with the cuff pilot.Due to the fact that the cuff was overinflated and couldn't be deflated, the scope could not pass through the distal end of the gastro.Consequently, the doc had to take out the lma and the patient was intubated." it was reported there was no injury to the patient.Patient condition 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 "lma gastro was inserted into patient.The cuff pilot was in the red and the cuff was clearly overinflated.The clinician tried to take air out of the cuff, and it couldn't be done.The syringe wasn't engaging properly with the cuff pilot.Due to the fact that the cuff was overinflated and couldn't be deflated, the scope could not pass through the distal end of the gastro.Consequently, the doc had to take out the lma and the patient was intubated." it was reported there was no injury to the patient.Patient condition reported as "fine".

• Brand Name: LMA GASTRO CUFF PILOT SIZE 4
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7161219
• MDR Text Key: 96486191
• Report Number: 9681900-2018-00001
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

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: Health Professional
• Device Expiration Date: 10/28/2019
• Device Catalogue Number: 1E5040
• Device Lot Number: LMB8D5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1