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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH
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TELEFLEX MEDICAL LMA PROSEAL SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH Back to Search Results
Model Number IPN922891
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2022
Event Type  malfunction  
Event Description
It was reported that "the red cap of the manual vent is missing" while in use on patient.Further information states that there were no issues with deflation/inflation of the cuff during use and that this was a re-sterilized device.An inflation/deflation test occurred prior to use however the missing cap was not noted.Patient status reported as "fine".See associated mdrs 9681900-2022-00032 and 9681900-2022-00033.
 
Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
 
Manufacturer Narrative
Qn#(b)(4).Three lma proseal were returned from customer on ground of "the red cap of the manual vent is missing".There was no patient involvement in the incident.There was no returned usage record card listing the date of initial use of the devices till its last use.There was no invoice date and invoice number given for validity of warranty.The device was manufactured in 2019.The red plug cap of the device was observed broken at the first glance upon receipt.The reported failure was verified as the lma could not hold cuff inflation with the red plug cap damage /missing.The outer profile of the return complaint samples looks yellowish / discolored due to multiple reuses.The red plug and its cap were the same component produced in the same molding.In order to simulate the process of shutting and opening of the red plug cap, a retained sample was used.It was observed that the red plug cap will not be stressed when it was handled properly.Dhr was reviewed.No abnormality was found.The customer is reminded that lma reusable is made of soft silicone rubber.It should be handled with care for re-using it and it is not supposed to hold the body weight of the device with the red plug cap itself.In addition, in case the red plug cap of the device was tangled with other objects, try not to use abrupt force to pull it.The root cause of the failure concluded as method of use related.
 
Event Description
It was reported that "the red cap of the manual vent is missing" while in use on patient.Further information states that there were no issues with deflation/inflation of the cuff during use and that this was a re-sterilized device.An inflation/deflation test occurred prior to use however the missing cap was not noted.Patient status reported as "fine".See associated mdrs 9681900-2022-00032 and 9681900-2022-00033.
 
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Brand Name
LMA PROSEAL SIZE 4
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTH
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
bryanna connelly
3015 carrington mill blvd
morrisville 27560
MDR Report Key15852634
MDR Text Key307893097
Report Number9681900-2022-00031
Device Sequence Number1
Product Code CAE
UDI-Device Identifier15060112318730
UDI-Public15060112318730
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/04/2022
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 Model NumberIPN922891
Device Catalogue Number150040
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/04/2022
Initial Date FDA Received11/23/2022
Supplement Dates Manufacturer Received12/22/2022
Supplement Dates FDA Received12/28/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
HYSTERECTOMY; HYSTERECTOMY
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