MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH ETT, SU, SIZE 7.0; LARYNGEAL MASK AIRWAY

Catalog Number 136070

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2014

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 cuff inflation line became detached.There was no reported patient harm.

Manufacturer Narrative

(b)(4).Device history record (dhr) review was performed on the reported defect of the production run and there were no issues found.The reported lot/batch passed the necessary requirements.Due to the lack of sample available the complaint could not be confirmed and no root cause could be determined.Therefore, no confirmation could be verified of whether the reported failure was due to user handling or a manufacturing defect.There will be continued monitoring and trending on issues related to this complaint.

Event Description

The event is reported as: the customer alleges the cuff inflation line became detached.There was no reported patient harm.

• Brand Name: LMA FASTRACH ETT, SU, SIZE 7.0
• 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: 5147026
• MDR Text Key: 28508686
• Report Number: 9681900-2015-00054
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 136070
• Device Lot Number: HBAA9U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2015
• 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