MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 192040

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer complaint alleges that the "cuff pilot didn't work".A photo with the complaint depics what appears to be a pilot cuff with a misshaped bellows.Alleged malfunction was reported as detected during use.There was no report of patient harm.It was reported there was no necessary medical intervention.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; however, the customer provided a photograph of the device.The photo was reviewed and it was observed that the cuff was over inflated.A sample of the same product code was taken from the manufacturing facility and functionally tested.No issues were encountered.As the sample was not returned, a proper investigation could not be conducted and a root cause was not established.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

Customer complaint alleges that the "cuff pilot didn't work".A photo with the complaint depics what appears to be a pilot cuff with a misshaped bellows.Alleged malfunction was reported as detected during use.There was no report of patient harm.It was reported there was no necessary medical intervention.

• Brand Name: LMA PROTECTOR CUFF PILOT 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6617232
• MDR Text Key: 76832124
• Report Number: 9681900-2017-00028
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

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 Catalogue Number: 192040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: 07/05/2017
• Supplement Dates FDA Received: 07/11/2017
• 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