CLEARLINK
Received Mar 30, 2026 · Event occurred Feb 14, 2026
Report 1416980-2026-01105 · MDR key 24719878
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C8750Catalog number
2C8750
Lot number
DR25J09024
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT TWO (2) CLEARLINK Y-TYPE BLOOD/SOLUTION SETS WITH STANDARD BLOOD FILTER LEAKED FROM THE MALE LUER. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS ADDED TO H6. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.