MEDEX EXTENSION SET
Received Aug 18, 2020 · Event occurred Jun 1, 2020
Report 3012307300-2020-08283 · MDR key 10423104
Device
Generic name
Intravascular Administration Set.
Manufacturer
Smiths Medical Asd, Inc.Model number
MX43660Catalog number
MX43660
Lot number
3912603
Product problems
- Crack
- Fluid/Blood Leak
- Crack
- Fluid/Blood Leak
Patient
Not reported
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
QUALITY COORDINATOR. NO PRODUCT WAS RETURNED FOR EVALUATION. RELEVANT DOCUMENTS WERE REVIEWED AND DEEMED ADEQUATE AND CORRECT WITH RESPECT TO INVESTIGATION ACTIVITIES. WITH NO PRODUCT RETURNED IN THIS CASE, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DEFINITELY ESTABLISHED. AFTER REVIEWING THE COMPLAINTS HISTORY FROM AUGUST 2017 TO DATE, IT WAS FOUND THAT THIS IS THE 1ST. COMPLAINT RELATED TO LEAKING STOPCOCK DEFECT.
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT THERE WAS A HAIRLINE CRACK IN THE STOPCOCK OF A SMITHS MEDICAL MEDEX EXTENSION SET ATTACHED TO A UVC LINE WAS FOUND AND LEAKING BLOOD. THE PATIENT REQUIRED IMMEDIATE TRANSFUSION AND INCREASED DOSAGE OF CARDIAC INFUSIONS.