FDA Adverse Event Malfunction Summary report: N

LMA CLASSIC, REU, SIZE 4 (100040)

MDR report key: 12217257 · Received July 23, 2021

Report

Report Number: 9681900-2021-00025
Event Type: Malfunction
Date Received: July 23, 2021
Date of Event: June 1, 2021
Report Date: June 1, 2021
Manufacturer: TELEFLEX MEDICAL
Product Code: CAE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

QN#: (B)(4). ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE SALES REP INDICATING THAT THE ISSUE WAS WITH THE PILOT BALLOON OF THE DEVICE AND NOT THE CUFF AS ORIGINALLY REPORTED. THE REP ALSO SENT A PHOTO OF THE DEVICE AND IT WAS OBSERVED THAT THERE WAS A LARGE TEAR IN THE PILOT BALLOON. THE USER WAS ABLE TO NOTICE THE LARGE TEAR AND THE DEVICE WAS NOT USED ON A PATIENT. AS THE DESCRIPTION OF THE EVENT IS DIFFERENT THAN WHAT WAS ORIGINALLY REPORTED, IT WAS DETERMINED THAT THIS IS NOT A REPORTABLE EVENT. THE INITIAL MDR SUBMITTED ON 07/23/2021 AND THE FOLLOW-UP MDR SUBMITTED ON 07/27/2021 SHOULD BE RETRACTED.

Additional Manufacturer Narrative · 0

QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. 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.

Description of Event or Problem · 0

IT WAS REPORTED "LMA CLASSIC HAD DEFLATED AFTER ONLY A FEW USES". NO PATIENT INVOLVEMENT REPORTED.

Additional Manufacturer Narrative · 1

QN#: (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED "LMA CLASSIC HAD DEFLATED AFTER ONLY A FEW USES". NO PATIENT INVOLVEMENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1117338	LMA CLASSIC, REU, SIZE 4 (100040)	LMA CLASSIC	CAE	TELEFLEX MEDICAL		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1				N/A.\| N/A.\| N/A.