INTERLINK
Received Dec 11, 2025
Report 1416980-2025-06032 · MDR key 23780412
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C6700Catalog number
2C6700
Lot number
R24J19024
Product problems
- Fluid/Blood Leak
- Detachment of Device or Device Component
- Fluid/Blood Leak
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3/D10: THE EVENT OCCURRED IN SEPTEMBER 2025. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE TUBING OF AN INTERLINK STRAIGHT TYPE BLOOD SET SEPARATED FROM THE DRIP CHAMBER. THE SET WAS SPIKED INTO THE BLOOD BAG (RBC) AND HUNG. WHILE PRIMING THE DRIP CHAMBER, THE INTRAVENOUS (IV) TUBING SEPARATED FROM THE DRIP CHAMBER, CAUSING BLOOD TO POUR FREELY FROM BOTH THE CHAMBER AND THE BAG UNTIL IT COULD BE RE-SPIKED WITH NEW STERILE BLOOD TUBING.