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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 3; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 3; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 192030
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2017
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 "the valve was so hard, (the user) couldn't set the syringe tip in the valve smoothly".Alleged defect reported as detected during testing prior to use.Customer reports a new device was obtained for use.Customer reports "no health injury occurred.".
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was performed and the cuff was inflated and deflated.It was found that there was slight difficulty to fully insert the syringe into the cuff pressure valve; however, no leaks were detected.
 
Event Description
Customer complaint alleges "the valve was so hard, (the user) couldn't set the syringe tip in the valve smoothly".Alleged defect reported as detected during testing prior to use.Customer reports a new device was obtained for use.Customer reports "no health injury occurred.".
 
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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 Key7147349
MDR Text Key95917153
Report Number9681900-2017-00050
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date12/28/2019
Device Catalogue Number192030
Device Lot NumberLMCAXU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2018
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 Number1
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