CLEARLINK
Received Feb 11, 2026 · Event occurred Dec 27, 2025
Report 1416980-2026-00550 · MDR key 24317146
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C8750Catalog number
2C8750
Lot number
NI
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION TO H11: UPON FURTHER CLARIFICATION THE BROKEN LUER COMPONENT WAS DETERMINED TO BE A NON-BAXTER PRODUCT. THEREFORE, THE BAXTER DEVICE IS NO LONGER SUSPECT IN THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT NUMBER WAS PROVIDED BY THE REPORTER. E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A CLEARLINK SYSTEM Y TYPE BLOOD/SOLUTION SET WAS ATTACHED TO THE PATIENT¿S LINE. WHEN THE TUBING WAS DISCONNECTED FROM THE PORT AND AN ATTEMPT WAS MADE TO PLACE A GREEN CURO CAP ON THE END OF THE Y TUBING, THE HUB DETACHED FROM THE LINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.