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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE CUFF PILOT, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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TELEFLEX MEDICAL LMA UNIQUE SILICONE CUFF PILOT, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 105200-000040
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/17/2017
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 seal of the cuff is not perfect." the customer alleges the clinical consequence was a "leak of the ventilation system".Alleged defect reported detected during use.There was no patient injury reported.The patient's condition was reported as "fine".
 
Manufacturer Narrative
(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 returned for evaluation.A visual exam was performed and it was observed that there was a hole in the inflation line.The origin of the hole is unknown.All products are 100% inspected at the manufacturing facility; therefore, a defect of this type would be detected prior to release.A conclusion code could not be found as the complaint was confirmed; however, a root cause could not be established.
 
Event Description
Customer complaint alleges "the seal of the cuff is not perfect." the customer alleges the clinical consequence was a "leak of the ventilation system".Alleged defect reported detected during use.There was no patient injury reported.The patient's condition was reported as "fine".
 
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Brand Name
LMA UNIQUE SILICONE CUFF PILOT, 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 Key7103787
MDR Text Key94409599
Report Number3011137372-2017-00384
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number105200-000040
Device Lot NumberMQAEWR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2017
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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