MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH, SU, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 135140

Device Problems Disconnection (1171); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "we have noticed a incompatibility between the green/orange masks and the blue filters.When we snap them in, they do not remain connected for long".Alleged issue reported occurred during patient use.No consequences for the patient were reported.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 could not be performed as the lot number provided by the customer is not a valid lot number.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 "we have noticed a incompatibility between the green/orange masks and the blue filters.When we snap them in, they do not remain connected for long".Alleged issue reported occurred during patient use.No consequences for the patient were reported.The patient condition was reported as "fine".

• Brand Name: LMA FASTRACH, SU, 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: 7619725
• MDR Text Key: 112022170
• Report Number: 9681900-2018-00028
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

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 Catalogue Number: 135140
• Device Lot Number: 374340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 07/26/2018
• 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