MAUDE Adverse Event Report: THE LARYNGEAL MASK COMPANY LMA SUPREME, SU, SIZE 4; LARYNGEAL MASK AIRWAY

Catalog Number 175040

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2015

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 cuff would not inflate during use.There was no reported harm to patient.

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 sample was not received in the original teleflex lma packaging and was observed to have been used.The airway tube was observed to be clear.There were no cracks or scratches observed on cuff.The cuff was inflated and deflated and there were no air leaks or deformation detected.The check valve was tested with a syringe and the valve was observed to function as intended.Sample received did not confirm the issue reported by the customer.The device is functioning as intended.

Event Description

The event is reported as: the customer alleges cuff would not inflate during use.There was no reported harm to patient.

• Brand Name: LMA SUPREME, SU, SIZE 4
• 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: 5208227
• MDR Text Key: 30647154
• Report Number: 9681900-2015-00060
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

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 Expiration Date: 08/28/2017
• Device Catalogue Number: 175040
• Device Lot Number: JMANZL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/06/2015
• 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