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BD LSRFORTESSA¿ SO Adverse Event — Malfunction (MDR 2916837-2020-00007)

BD LSRFORTESSA¿ SO Adverse Event — Malfunction (MDR 2916837-2020-00007) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BD LSRFORTESSA¿ SO; Generic name: N/A; Manufacturer: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES.

DeviceBD LSRFORTESSA¿ SO
Generic nameN/A
ManufacturerBECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
Report number2916837-2020-00007
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceFOREIGN, OTHER, USER FACILITY
NarrativeIT WAS REPORTED THAT SHEATH FLUID LEAKED OUTSIDE OF THE INSTRUMENT WITH A BD LSRFORTESSA¿ SO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED THAT THE LEAK WAS NOT CONTAINED IN THE INSTRUMENT AND THAT IT WAS IN A CUSTOMER ACCESSIBLE LOCATION. HE STATED THE FLUID THAT LEAKED WAS FACSFLOW AND WASTE. VERIFIED SYSTEM IS ASPIRATING SAMPLE. VERIFIED PRIME DOES PRODUCE BUBBLES IN T
SourceopenFDA MAUDE (device adverse events)

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