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

Catalog Number 192030

Device Problem Deflation Problem (1149)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges that "the cuff of the device would not deflate on checking prior to use so could not be used." customer reports there was no patient involvement.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was a syringe attached to the sample.Inflation and deflation testing was performed on the returned sample and difficulty was encountered when inserting the syringe into the cuff pressure valve.A pin gauge test was conducted and it was found that the diameter of the pilot cuff was out of specification.Ten random pieces of the product were selected from production at the manufacturing facility.All samples were found to be within specification.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.No leakage was found on the returned sample; however, it was found that there was some difficulty inserting the syringe into the pilot cuff valve.It was determined that the inner diameter of the outer cylinder female connector port was out of specification.The root cause is manufacturer related.Relevant parties were made aware of this issue.

Event Description

Customer complaint alleges that "the cuff of the device would not deflate on checking prior to use so could not be used." customer reports there was no patient involvement.

Manufacturer Narrative

(b)(4).Additional information provided.Information which had been previously provided by the component supplier to lma singapore was deemed inaccurate and following further clarification it was established that the device was not non-conforming.During testing, the cuff was able to be deflated and inflated.It was observed that there is slight difficulty to fully insert syringe into cuff pressure valve; however, there were no leaks detected.The complaint sample was functional.

Event Description

Customer complaint alleges that "the cuff of the device would not deflate on checking prior to use so could not be used." customer reports there was no patient involvement.

• Brand Name: LMA PROTECTOR 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: 6928989
• MDR Text Key: 89948770
• Report Number: 9681900-2017-00043
• 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,Followup
• Report Date: 09/20/2017

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: No Information
• Device Expiration Date: 12/28/2019
• Device Catalogue Number: 192030
• Device Lot Number: LMCAXU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 11/07/2017; 11/30/2017
• Supplement Dates FDA Received: 11/08/2017; 02/06/2018
• Was Device Evaluated by Manufacturer?: No
• 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