Patient Problem
No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
Event Type
malfunction
Manufacturer Narrative
Investigation completed on a the pain management|portex kits other epifuse connector.The complaint of hinge broken was verified.No discrepancies found in manufacturing of device.The cause and timing was not identified, however continuous monitoring of the device observed for future trends.
Event Description
Reported a smiths medical pain management|portex kits epifuse connector did not have a problem in connection during the use of it.However, leakage of medical fluid from it was observed.So the customer disconnected the epifuse connector from the mating component and noticed the hinge part was broken.No patient injury.