MEDLINE
Received Apr 10, 2026 · Event occurred Mar 26, 2026
Report 3004122598-2026-00003 · MDR key 24840270
Device
Generic name
Whole Blood Draw Phlebotomy
Manufacturer
Productos Medline S.a. De C.v.Catalog number
DYNDB3035I
Lot number
25LBE089
Product problems
- Fluid/Blood Leak
- Material Perforation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED ON (B)(6) 2026 THAT DURING A WHOLE BLOOD PHLEBOTOMY PROCEDURE, HOLES WERE DISCOVERED IN BLOOD COLLECTION TEST TUBES. THE DEFECT WAS IDENTIFIED WHILE FILLING THE TEST TUBES FROM THE DIVERSION POUCH. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. 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
IT WAS REPORTED ON (B)(6) 2026 THAT DURING A WHOLE BLOOD PHLEBOTOMY PROCEDURE, HOLES WERE DISCOVERED IN BLOOD COLLECTION TEST TUBES. THE DEFECT WAS IDENTIFIED WHILE FILLING THE TEST TUBES FROM THE DIVERSION POUCH.