RUSCH EB CARLENS W/CARINA HOO

MDR report key: 6076626 · Received November 3, 2016

Report

Report Number: 8040412-2016-00248
Event Type: Malfunction
Date Received: November 3, 2016
Date of Event: July 26, 2016
Report Date: October 26, 2016
Manufacturer: TELEFLEX MEDICAL
Product Code: BTS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE INVESTIGATION OF THIS COMPLAINT IS IN PROGRESS AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative · 1

(B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO DEFECTS WERE OBSERVED. THE CUFF PRESSURE WAS THEN TESTED BY INFLATING THE CUFFS TO 25 MBAR USING A CALIBRATE ENDO TEST METER. IT WAS OBSERVED THAT THE BLUE CUFF COULD NOT MAINTAIN PRESSURE. THE SAMPLE WAS IMMERSED INTO A WATER BATH AND IT WAS OBSERVED THAT AIR BUBBLES WERE COMING FROM THE BLUE CUFF. CLOSER INSPECTION OF THE LEAKAGE AREA REVEALED THAT THERE WAS A CUT MARK ON THE SURFACE OF THE CUFF. THE COMPLAINT OF "BLUE CUFF LEAKING PRIOR TO USE" WAS CONFIRMED. AS THE FAILURE WAS DETECTED PRIOR TO USE IT IS POSSIBLE THAT THE DEFECT OCCURRED DURING MANUFACTURING. A NON-CONFORMANCE WAS OPENED TO ADDRESS THIS ISSUE.

Description of Event or Problem · 1

CUSTOMER COMPLAINT ALLEGES THAT THE DOCTOR "FOUND BLUE CUFF LEAKAGE PRIOR TO USE ON PATIENT DURING FUNCTIONAL TEST."

Description of Event or Problem · 1

CUSTOMER COMPLAINT ALLEGES THAT THE DOCTOR "FOUND BLUE CUFF LEAKAGE PRIOR TO USE ON PATIENT DURING FUNCTIONAL TEST."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
726079	RUSCH EB CARLENS W/CARINA HOO	BRONCHIAL TUBE	BTS	TELEFLEX MEDICAL		13IT16

Patients

Seq	Age	Sex	Outcome	Treatment
1