MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) CPV SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 105200-000050

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "the valve on the cuff pilot is stuck.Doctor could not inflate or deflate the lma." alleged issue reported occurred during a patient use.No patient injury or consequence reported.Patient condition reported as fine.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and no damage was observed on the outer profile of the device.The device was then functionally tested and the cuff could be inflated and deflated without any issues.Based on the investigation performed, the reported complaint could not be confirmed.The returned device was found to be fully functional.

Event Description

Customer complaint alleges "the valve on the cuff pilot is stuck.Doctor could not inflate or deflate the lma." alleged issue reported occurred during a patient use.No patient injury or consequence reported.Patient condition reported as fine.

• Brand Name: LMA UNIQUE (SILICONE CUFF) CPV SIZE 5
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8336906
• MDR Text Key: 136735014
• Report Number: 3011137372-2019-00045
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

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 Catalogue Number: 105200-000050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1