SILKO REBREATHING BAG 2.3
Received Sep 27, 2018 · Event occurred Aug 31, 2018
Report 9610520-2018-00012 · MDR key 7915066
Device
Generic name
Device, Rebreathing
Manufacturer
Teleflex MedicalCatalog number
150700-000023
Lot number
P1442942
Product problems
- Gas/Air Leak
- Gas/Air Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE BALLOON LEAKED DUE TO A HOLE NEAR THE SEAL OF THE STRAINING CLAMP. THUS, THE ANESTHESIA VENTILATOR FAILED ITS TESTS. AS A RESULT THERE WAS A REPORT OF A DELAY; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION DUE TO THE DELAY.
Additional Manufacturer Narrative
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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
IT WAS REPORTED THAT THE BALLOON LEAKED DUE TO A HOLE NEAR THE SEAL OF THE STRAINING CLAMP. THUS, THE ANESTHESIA VENTILATOR FAILED ITS TESTS. AS A RESULT THERE WAS A REPORT OF A DELAY; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION DUE TO THE DELAY.
Description of Event or Problem
IT WAS REPORTED THAT THE BALLOON LEAKED DUE TO A HOLE NEAR THE SEAL OF THE STRAINING CLAMP. THUS, THE ANESTHESIA VENTILATOR FAILED ITS TESTS. AS A RESULT THERE WAS A REPORT OF A DELAY; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION DUE TO THE DELAY.
Additional Manufacturer Narrative
(B)(4). THE SAMPLE WAS RETURNED AND SENT TO THE MANUFACTURER (DEGANIA) FOR EVALUATION. DEGANIA REPORTS THAT UPON VISUAL INSPECTION THE BAG LOOKED USED AND HAD A HOLE NEAR THE SEAL. A DHR REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. RETAINED SAMPLES WERE INSPECTED AND NO ISSUES WERE FOUND. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. THE BATCH HISTORY REVIEW DID NOT REVEAL ANY NON-CONFORMITIES AND THE RETAINED SAMPLES WERE INSPECTED AND NO ISSUES WERE FOUND. THE ACTUAL SAMPLE WAS USED FOR SOME TIME BEFORE THE LEAKAGE OCCURRED. IT WAS DETERMINED THAT THE BAG WAS DAMAGED DURING USE.