MEDEX STOPCOCKS INFUSION EXTENSION SETS AND DISPOS
Received Apr 24, 2023 · Event occurred Feb 10, 2022
Report 3012307300-2023-04453 · MDR key 16797005
Device
Generic name
Infusor, Pressure, For I.v. Bags
Manufacturer
Smiths Medical Asd, Inc.Product problems
- Leak/Splash
- Insufficient Flow or Under Infusion
- Leak/Splash
- Insufficient Flow or Under Infusion
Patient
Unknown
- Low Blood Pressure/ Hypotension
- Low Blood Pressure/ Hypotension
Narrative
Additional Manufacturer Narrative
OTHER, OTHER TEXT: THIS MDR WAS GENERATED UNDER PROTOCOL B10010116, AS A RESULT OF WARNING LETTER CMS# 617147. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. D5: OPERATOR OF DEVICE IS UNKNOWN. E4: INITIAL REPORTER ALSO SENT REPORT TO FDA IS UNKNOWN. D4: CATALOG NUMBER IS UNKNOWN. D4: UDI INFORMATION IS UNKNOWN. G5: PREMARKET (510K) NUMBER IS UNKNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THE PRODUCT WAS LEAKING AND GIVING THE PATIENT HIGH DOSE OF PRESSOR. THIS WAS CAUSING PATIENT'S BLOOD PRESSURE DETERIORATION. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.