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

Catalog Number 1D2040

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

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 still in process.

Event Description

Customer complaint alleges "the manometer's internal bellow did not move as the clinician inserted air into the cuff.They pulled the lma and tested it outside the patient, and it still did not move as they visualized the cuff fill with air".Alleged defect was detected during use.No report of patient harm or consequence.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The sample was not returned for evaluation.A reserve sample was selected at the manufacturing facility and functional testing was performed.The cuff was able to inflate and deflate without issues.As the actual complaint sample was not returned, the complaint could not be confirmed.The sample is needed in order to perform a proper investigation and determine a root cause.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

Customer complaint alleges "the manometer's internal bellow did not move as the clinician inserted air into the cuff.They pulled the lma and tested it outside the patient, and it still did not move as they visualized the cuff fill with air".Alleged defect was detected during use.No report of patient harm or consequence.Patient condition reported as "fine".

• Brand Name: LMA UNIQUE EVO, CUFF PILOT, SU, SIZE 4
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6398434
• MDR Text Key: 69737083
• Report Number: 3011137372-2017-00062
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

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: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1D2040
• Device Lot Number: LQAES3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1