MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA GASTRO CUFF PILOT SIZE 3; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 1E5030

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The investigation into this complaint is still in progress.The device involved in this complaint has been returned to the manufacturer.However, the investigation of said device has not been completed at the time of this report.This report will be updated at the conclusion of the investigation.

Event Description

Customer complaint alleges "prior to use we were ready to go with the case, and when the crna went to deflate the cuff the cuff did not deflate.We tried another lma and the same issue occurred while the patient was on the table (2nd event captured in mfr rpt# 9681900-2017-00032)." there was no report of patient harm.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.It was noticed there was no syringe returned with the sample.A visual exam was performed and no defects were observed.Functional testing was performed with two different types of syringes and cpv venting tools.No issues were found with inflation and deflation of the device.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The cuff was able to be inflated and deflated using two types of syringes, and no leaks were detected.

Event Description

Customer complaint alleges "prior to use we were ready to go with the case, and when the crna went to deflate the cuff the cuff did not deflate.We tried another lma and the same issue occurred while the patient was on the table (2nd event captured in mfr rpt# 96 81900-2017-00032)." there was no report of patient harm.Patient condition reported as "fine".

• Brand Name: LMA GASTRO CUFF PILOT SIZE 3
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6753489
• MDR Text Key: 81433043
• Report Number: 9681900-2017-00031
• 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: 07/13/2017

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 Expiration Date: 11/28/2019
• Device Catalogue Number: 1E5030
• Device Lot Number: LMCBPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 07/31/2017
• Supplement Dates Manufacturer Received: 09/03/2017
• Supplement Dates FDA Received: 09/04/2017
• 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