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

Catalog Number 136070

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2016

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 et tube was unable to be removed during use.There was no patient harm reported.

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.Device was used and not in the original teleflex lma packaging.The airway was observed to be clear.The ett connector was observed to be damaged upon receipt.The ett connector was firmly inserted into the elbow connector and only after many attempts with huge force that the connector was able to be removed from the elbow connector.A retained sample was compared to the complaint sample and there was no significant difference between the two samples.There was no leakage at the joint between the two components when water was poured into the elbow connector.The connector was easily removed from the circuit elbow connector.The gap of the two components in the test is wider than the returned complaint connector.Ett connector does not need to be inserted with force into the circuit elbow connector.As long as no leakage between the two components at the joint, the connector will not be difficult to be removed.

Event Description

The event is reported as: the customer alleges the et tube was unable to be removed during use.There was no patient harm reported.

• 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: 6184214
• MDR Text Key: 62690438
• Report Number: 9681900-2016-00059
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

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: Health Professional
• Device Expiration Date: 11/28/2018
• Device Catalogue Number: 136070
• Device Lot Number: KBABJ6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• 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: Initial
• Patient Sequence Number: 1