CAP CHANGE KIT
Received Sep 13, 2023 · Event occurred Jul 23, 2023
Report 1417592-2023-00373 · MDR key 17736677
Device
Product problems
- Leak/Splash
- Leak/Splash
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY ON (B)(6) 2023 "THE MICROBORE CAP WAS BROKEN ALLOWING THEIR HYDROCORTISONE INFUSION TO LEAK OUT". PER THE FACILITY THEY ARE UNSURE IF THE PATIENT RECEIVED ANY OF THE MEDICATION THAT WAS SCHEDULED TO BE ADMINISTERED. PER THE FACILITY THE PATIENT WAS NOT INJURED AND IT IS UNKNOWN IF THE PATIENT REQUIRED ADDITIONAL MEDICATION. THE DEVICE WAS REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
ACCORDING TO THE FACILITY ON (B)(6) 2023 "THE MICROBORE CAP WAS BROKEN ALLOWING THEIR HYDROCORTISONE INFUSION TO LEAK OUT".