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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE CUFF PILOT, SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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TELEFLEX MEDICAL LMA UNIQUE SILICONE CUFF PILOT, SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 105200-000050
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has been returned to the manufacturer.However, the investigation of said device is still in progress at the time of this report.
 
Event Description
Customer complaint alleges "the crna's were doing a pre-check and they inflated the pilot balloon, but it would not deflate." the alleged defect was detected prior to use.There was no patient harm reported.There was no report of delay in treatment.
 
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.Inflation and deflation testing was performed on the cuff and no issues were detected.The sample was inspected and it was found that the cpv size met the requirements.The reported complaint could not be confirmed.
 
Event Description
Customer complaint alleges "the crna's were doing a pre-check and they inflated the pilot balloon, but it would not deflate." the alleged defect was detected prior to use.There was no patient harm reported.There was no report of delay in treatment.
 
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Brand Name
LMA UNIQUE SILICONE CUFF PILOT, SIZE 5
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 Key6286373
MDR Text Key66336090
Report Number3011137372-2017-00023
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/16/2017
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 Date11/01/2019
Device Catalogue Number105200-000050
Device Lot NumberLQAFQ7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/16/2017
Initial Date FDA Received01/30/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
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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