ARTERIAL LINE KIT/1 18 GA
Received Jul 2, 2020 · Event occurred Jun 16, 2020
Report 1625425-2020-00385 · MDR key 10226560
Device
Generic name
Stopcock
Manufacturer
Argon Medical DevicesModel number
498104Catalog number
498104
Lot number
UNKNOWN
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE SAMPLE IS INDICATED AS UNAVAILABLE FOR EVALUATION. WITHOUT SUCH EVIDENCE, THE COMPLAINT CANNOT BE CONFIRMED AND THE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE PROVIDED.
Description of Event or Problem
PROPOFOL INFUSION WAS LEAKING THOUGH THE STOPCOCK WITHOUT ANY OBVIOUS CRACK. PATIENT LIKELY DID NOT RECEIVE PROPOFOL INFUSION BUT OTHER IV INFUSIONS. STOPCOCK HAD TO BE CHANGED.
Additional Manufacturer Narrative
H3 OTHER TEXT : PLACEHOLDER.
Description of Event or Problem
FOLLOW UP.
Remedial action
- Other