FDA Adverse Event Malfunction Summary report: N

LMA CLASSIC, REU, SIZE 3 (100030)

MDR report key: 9038961 · Received September 13, 2019

Report

Report Number: 9681900-2019-00037
Event Type: Malfunction
Date Received: September 13, 2019
Date of Event: August 18, 2019
Report Date: August 21, 2019
Manufacturer: TELEFLEX MEDICAL
Product Code: CAE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

QN#(B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND THE AIRWAY TUBE LOOKS LIGHTLY YELLOWISH DUE TO MULTIPLE USES. THE CHECK VALVE WAS INSPECTED AND IT WAS FUNCTIONING PROPERLY. THIS MEANS AIR CAN BE BLOWN IN AND REMOVED FROM THE DEVICE SMOOTHLY WITH A SYRINGE AND NO BLOCKAGE WAS DETECTED. WHEN THE DEVICE WAS INFLATED WITH 1X THE RECOMMENDED AIR VOLUME, NO ISSUES WERE DETECTED; HOWEVER, WHEN THE DEVICE WAS INFLATED WITH 1.5X THE RECOMMENDED VOLUME OF AIR, A HERNIATION WAS OBSERVED IN THE CUFF. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. OVER-INFLATION IS A KNOWN CAUSE THAT LEADS TO CUFF HERNI ATION.

Description of Event or Problem · 0

THE CUSTOMER REPORTED HERNIATION OF THE CUFF DURING USE. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO INTERVENTION OR PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED HERNIATION OF THE CUFF DURING USE. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO INTERVENTION OR PATIENT HARM WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
811627	LMA CLASSIC, REU, SIZE 3 (100030)	AIRWAY, OROPHARYNGEAL, ANESTHE	CAE	TELEFLEX MEDICAL		82SAFNUR

Patients

Seq	Age	Sex	Outcome	Treatment
1				NONE REPORTED.\| NONE REPORTED.