MAUDE Adverse Event Report: THE LARYNGEAL MASK COMPANY LMA FASTRACH ETT, SU, SIZE 8.0; LARYNGEAL MASK AIRWAY

Catalog Number 136080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2015

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 would not stay inflated during testing.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.All processes were executed according to the standard operating methods.The device was received opened in the original teleflex lma packaging (pouch).The device was observed to have a clear airway.There was a hole verified in the inflation line.The device was tested and the reported failure was confirmed.A retained sample was compared to the defective sample.There was no hole observed on the inflation line of the retained sample.In addition, the retained sample could hold air and remained inflated when tested.A conclusion code could not be chosen as the complaint was confirmed however, a root cause could not be established.Whether the product failure was due to handling or other reasons the investigation was unable to identify the root cause.There will be further monitoring of complaints with the same reported issue.

Event Description

The event is reported as: the customer alleges the cuff would not stay inflated during testing.There was no reported patient involvement.

• Brand Name: LMA FASTRACH ETT, SU, SIZE 8.0
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): THE LARYNGEAL MASK COMPANY; singapore
• 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: 5216889
• MDR Text Key: 30991066
• Report Number: 9681900-2015-00061
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

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: 136080
• Device Lot Number: GBABFJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2015
• 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: Initial
• Patient Sequence Number: 1