BLOOD RECIPIENT SET
Received Jun 25, 2026 · Event occurred Apr 23, 2026
Report 1416980-2026-02126 · MDR key 25619983
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
JC7751Catalog number
JC7751
Lot number
DR25L17086
Product problems
- Fluid/Blood Leak
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER FACILITY NAME: (B)(6). H11: THE DEVICE WAS DISCARDED; 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 SPIKE OF A Y TYPE BLOOD/SOLN SET DETACHED FROM THE TUBING AND RESULTED IN LEAKAGE. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.