RUSCH STRETCH NECK REBREATH BAG
Received Oct 11, 2017 · Event occurred Sep 21, 2017
Report 8040412-2017-00216 · MDR key 6941243
Device
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, TWO SAMPLES WERE TAKEN FROM CURRENT PRODUCTION AT THE MANUFACTURING FACILITY. A COMPARISON WAS CONDUCTED BETWEEN SIZE 1L AND 2L. THE DIMENSION OF THE NECK WHERE THE PRODUCT ATTACHES TO THE MACHINE WAS CHECKED FOR LENGTH, DIAMETER, AND THICKNESS. THE PRODUCTION SAMPLES WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE ANALYSIS OF THE SAMPLES TAKEN FROM CURRENT PRODUCTION, THE DIMENSIONS MET THE MANUFACTURING SPECIFICATION. LACK OF BREATHING MAY COME FROM VARIOUS SOURCES SUCH AS IMPROPER CONNECTION, PINHOLES, OR BAGS MAY WEAKEN DUE TO OVERAGE OF THE MAXIMUM 20 CYCLES OF CLEANING. 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
CUSTOMER COMPLAINT ALLEGES THERE IS A LEAK WHERE THE BAG "CONNECTS TO THE MACHINE". ALLEGED DEFECT REPORTED AS DETECTED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.
Additional Manufacturer Narrative
(B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.
Description of Event or Problem
CUSTOMER COMPLAINT ALLEGES THERE IS A LEAK WHERE THE BAG "CONNECTS TO THE MACHINE". ALLEGED DEFECT REPORTED AS DETECTED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.