MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH, SU, SIZE 5; LARYNGEAL MASK AIRWAY

Catalog Number 135150

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The event is reported as: the customer alleges the probe was difficult to insert during intubation.There is no reported harm to the patient.

Manufacturer Narrative

Qn#(b)(4).Correction: catalog# - changed from 13150 to 135150.Device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.Along with the fastrach device an ett device was also sent to assist in duplicating the reported issue.The connector was observed to be clear.The fastrach was not received in the original teleflex lma packaging however the ett device was unsealed.The outer profile of the returned devices looked standard.There was no physical damage observed.The reported failure was due to method of use related as ett single use 7.5mm is not a recommended size for use in fastrach single use.Customer is reminded to use fastrach single use ett size 7.0mm or smaller with fastrach single use mask (of any size).

Event Description

The event is reported as: the customer alleges the probe was difficult to insert during intubation.There is no reported harm to the patient.

• Brand Name: LMA FASTRACH, SU, SIZE 5
• Type of Device: LARYNGEAL MASK AIRWAY
• 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: warrenda peterson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 6144625
• MDR Text Key: 61448262
• Report Number: 9681900-2016-00053
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

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: 135150
• Device Lot Number: KPAB4M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1