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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 4; AIRWAY, OROPHARYNGEAL, ANESTH
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TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 4; AIRWAY, OROPHARYNGEAL, ANESTH Back to Search Results
Model Number IPN922772
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2022
Event Type  malfunction  
Event Description
Reported issue: prior to use on patient, while testing the lma, the provider was not able to deflate the lma even after changing the syringe used 3 separate times.The reported defect was detected prior to use in a clinical setting.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
Reported issue: prior to use on patient, while testing the lma, the provider was not able to deflate the lma even after changing the syringe used 3 separate times.The reported defect was detected prior to use in a clinical setting.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Manufacturer Narrative
(b)(4).The product received with disinfection tag and product com plaint description.A deflate and inflate test was carried out to test the product functionality and cpv is working or not.Result 'passed' as the product can be deflated and inflated with no issue and no leak was observed.Cpv is connected well to the syringe.The product was fully deflated.The product was inflated until the cpv indicator moves to green.The product was inflated more until the cpv indicator moves to red zone.The dhr was reviewed and no abnormalities were found.Assembly dhr for the cuff pilot valve (cpv) used was reviewed and there was no issue with the cpv lot used for the final assembly product.Based on the review of the ohr and nonconformance (nc) list, there is no issue of product cannot be deflated were found related with the finished packaging or assembly product lot.Based on the testing performed on the sample received, the product was able to be deflated and inflated.No leak is observed, and the test conclude that the sample has no problem.Therefore, the root cause after the complaint sample received and review is "no problem found on sample".Based on the complaint description of "does not deflate - prior to use", reviewing of the ohr of the packaging and assembly lot, reviewing the nc list, and review the complaint sample, it is concluded that the complaint root cause is "no problem found on the sample".Therefore, no further escalation or action is required.
 
Event Description
Reported issue: prior to use on patient, while testing the lma, the provider was not able to deflate the lma even after changing the syringe used 3 separate times.The reported defect was detected prior to use in a clinical setting.There was no patient involvement.
 
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Brand Name
LMA UNIQUE (SILICONE) CUFF PILOT 4
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTH
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
bryanna connelly
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key15890289
MDR Text Key307677821
Report Number3011137372-2022-00229
Device Sequence Number1
Product Code CAE
UDI-Device Identifier15060112318181
UDI-Public15060112318181
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN922772
Device Catalogue Number105200-000040
Device Lot Number11F22E0053
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received02/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
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