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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4

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TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4 Back to Search Results
Model Number IPN047898
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Airway Obstruction (1699)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported ""the insertion of the lma protector was difficult, the anaesthesia was deepened, the lma protector was removed from the mouth and a gudel tube was inserted for a light mask ventilation.During the insertion of the guedel tube, a foreign part was discovered in the patient's throat.This part, a small plastic ring was removed out of the patient's throat.This ring is usually at the tip of the lma tube".No patient injury or harm reported.Patient condition reported as "fine".
 
Event Description
It was reported ""the insertion of the lma protector was difficult, the anaesthesia was deepened, the lma protector was removed from the mouth and a gudel tube was inserted for a light mask ventilation.During the insertion of the guedel tube, a foreign part was discovered in the patient's throat.This part, a small plastic ring was removed out of the patient's throat.This ring is usually at the tip of the lma tube".No patient injury or harm reported.Patient condition reported as "fine".
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports a visual exam was performed and it was observed that the small plastic ring (seen in a photo provided by the customer) that was reported detached from the lma protector was not returned along with the sample.The manufacturer also reports "both areas (backplate distal end and drain tube to backplate gluing area) have the presence of the glue on the jointing area.There was no clear evidence that an excess glue was detached from both area.Furthermore, the foreign part (small plastic ring) as per complaint description was not available with complaint sample to further investigate and match to identify which location the foreign material origin from." a device history record review was performed and no relevant findings were identified.Based on the investigation performed, the complaint was confirmed; however, a root cause could not be established.
 
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Brand Name
LMA PROTECTOR CUFF PILOT SIZE 4
Type of Device
LMA PROTECTOR
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key11740411
MDR Text Key257239281
Report Number9681900-2021-00011
Device Sequence Number1
Product Code CAE
UDI-Device Identifier05060112313868
UDI-Public05060112313868
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/09/2021
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 No Information
Device Expiration Date12/28/2022
Device Model NumberIPN047898
Device Catalogue Number192040
Device Lot NumberPMDFZB
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/09/2021
Initial Date FDA Received04/28/2021
Supplement Dates Manufacturer Received05/28/2021
Supplement Dates FDA Received05/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUDEL TUBE; GUDEL TUBE
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