ANES CIRCUIT, PED, 108 IN EXP, 1L BAG
Received Mar 16, 2023 · Event occurred Jan 10, 2023
Report 8030673-2023-00303 · MDR key 16554284
Device
Generic name
Circuit, Breathing (w Connector, Adaptor, Y Piece)
Manufacturer
Productos Urologos De Mexico S.a. De C.v.Model number
ANES CIRCUIT, PED, 108 IN EXP, 1L BAGCatalog number
B1714XXX
Lot number
0004223761
Product problems
- Leak/Splash
- Leak/Splash
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE B1714XXX ANES CIRCUIT, PED, 108 IN EXP, 1L BAG WAS LEAKING. THE PRODUCT WAS IN THE PROCESS OF BEING ATTACHED TO THE PATIENT WHEN THE DAMAGE WAS FOUND. IT WAS NOTICED WHEN THE TUBING WAS EXTENDED AND THE ANESTHESIA GAS BEGAN TO LEAK. A NEW CIRCUIT WAS OBTAINED AND USED IN PLACE OF THE FAULTY PRODUCT. THERE WAS NO HARM BUT THIS ISSUE CAUSE A DELAY OF TREATMENT.
Additional Manufacturer Narrative
RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS RETURNED TO VYAIRE MEDICAL. THE UNIT WAS FUNCTIONALLY INSPECTED BY QUALITY PERSONNEL FROM THE ASSEMBLY AREA, WHO PERFORMED A LEAK TEST ON THE SAMPLE, WHICH FAILED. IT WAS DISCOVERED THAT THE TUBE PART NUMBER R5108MEXA HAD A HOLE, WHICH WAS CAUSING THE LEAK ISSUE. THE ROOT CAUSE WAS IDENTIFIED AND TRACED BACK TO THE OPERATIONAL CONTEXT THAT CAUSED OR CONTRIBUTED TO THE EVENT.