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

Catalog Number 175040

Device Problem Leak/Splash (1354)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint received via med watch report (mw5072065) form by teleflex.Event type reported as serious injury, however, no serious injury apparent in the event description text.Event outcome reported as medical intervention.Event description reports a manipulation of the device in situ, with device removal upon completion of the surgical procedure.Report indicates the device is not available for investigation.Lot number not provided.No follow up with customer is possible due to lack of customer information provided by the reporter.The investigation not this complaint is still in progress at the time of this report.

Event Description

Complaint received via medwatch (mw5072065)alleges: "large air leak noted approx 90 mins of insertion of device.Manipulation of the device in situ in order to alleviate air leak was initiated.Upon completion of surgical procedure and removal of the supraglottic airway, a large dent was noted where the cuff of the supraglottic airway connected to the curved shaft of the device.".

Manufacturer Narrative

(b)(4).Visual, dimensional, and functional investigation of the device involved could not be performed as no device, or a picture of the alleged defect reported was returned for evaluation.A device history record review could not be conducted as no lot number was provided.Customer complaint cannot be confirmed based on the information received.In order to perform a proper and thorough investigation it is necessary to have the device sample.If the device sample becomes available at a later date, this report will be updated accordingly.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Complaint received via medwatch (mw5072065)alleges: "large air leak noted approx 90 mins of insertion of device.Manipulation of the device in situ in order to alleviate air leak was initiated.Upon completion of surgical procedure and removal of the supraglottic airway, a large dent was noted where the cuff of the supraglottic airway connected to the curved shaft of the device.".

• Brand Name: LMA SUPREME, 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: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6969927
• MDR Text Key: 90753513
• Report Number: 9681900-2017-00046
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

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 Catalogue Number: 175040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 10/24/2017
• 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