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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE PILOT BALLOON SZ 2.5; AIRWAY, OROPHARYNGEAL, ANESTH
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TELEFLEX MEDICAL LMA UNIQUE SILICONE PILOT BALLOON SZ 2.5; AIRWAY, OROPHARYNGEAL, ANESTH Back to Search Results
Catalog Number 105300-000025
Device Problem Disconnection (1171)
Patient Problem Hypoxia (1918)
Event Date 06/16/2023
Event Type  Injury  
Event Description
It was reported that "during surgery, the child's airway was secured with lma unique silicon, and oxygen saturation decreased during surgery, and the respiratory curve was not visible on the monitor.The doctor found that the cause was that the laryngeal mask that had been inserted had become disconnected.The breathing tube became detached from the cuff of the laryngeal mask, causing hypoxia." further information received states that this occurred towards the end of the procedure, the patient was in the supine position throughout the entire procedure.The detached cuff was retrieved from the patient by the "inflation tube".A new lma was not inserted as the procedure had already been completed.There were no other clinical signs or symptoms of hypoxia noted and the pulse oxygenation probe on the finger was checked during the event to ensure proper connection.Besides oxygen desaturation, there was no other patient harm, injury, or permanent impact.The procedure was able to be completed successfully.The patient status is reported as "fine" as they were discharged home.
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be completed as no lot number was provided.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 sample was returned by the customer and sent to the manufacturing site for investigation.The complaint was able to be confirmed by the manufacturing site as the product was found to be detached between the airway tube and the backplate.The manufacturing site also reports that a non-conformance was opened to address the issue.
 
Event Description
It was reported that "during surgery, the child's airway was secured with lma unique silicon, and oxygen saturation decreased during surgery, and the respiratory curve was not visible on the monitor.The doctor found that the cause was that the laryngeal mask that had been inserted had become disconnected.The breathing tube became detached from the cuff of the laryngeal mask, causing hypoxia." further information received states that this occurred towards the end of the procedure, the patient was in the supine position throughout the entire procedure.The detached cuff was retrieved from the patient by the "inflation tube".A new lma was not inserted as the procedure had already been completed.There were no other clinical signs or symptoms of hypoxia noted and the pulse oxygenation probe on the finger was checked during the event to ensure proper connection.Besides oxygen desaturation, there was no other patient harm, injury, or permanent impact.The procedure was able to be completed successfully.The patient status is reported as "fine" as they were discharged home.
 
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Brand Name
LMA UNIQUE SILICONE PILOT BALLOON SZ 2.5
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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17317366
MDR Text Key319185894
Report Number9681900-2023-00018
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeEZ
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 06/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number105300-000025
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/19/2023
Initial Date FDA Received07/13/2023
Supplement Dates Manufacturer Received07/27/2023
Supplement Dates FDA Received08/01/2023
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
Patient Age7 YR
Patient SexFemale
Patient Weight25 KG
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