MEDEX TRANSTAR BLOOD SAMPLE KIDS KIT

Additional Manufacturer Narrative

THIRTY NINE(39) UNUSED DEVICES WERE EFFECT AND TWO DEVICES WERE TESTED FOR EVALUATION. THE TUBING WAS CRACKED RESULTING IN AIR IN THE LINE AND LEAKED (AIR LINE/ LEAKING) WAS CONFIRMED THROUGH THE DEVICE ANALYSIS, SINCE 2 OUT OF 35 RETURNED SAMPLES LEAKED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. MRN REFERENCE NUMBER: (B)(4).

Description of Event or Problem

THE DEVICE WAS RETURNED BECAUSE THE TRANSTAR@ KIDS KIT 19IN CLOSED BLOOD SAMPLE KIT 10/CA TUBING WAS CRACKED. DURING THE PHYSICAL INSPECTION, AIR IN THE LINE AND LEAKAGE WERE OBSERVED. PATIENT INVOLVEMENT IS UNKNOWN, AND NO PATIENT HARM OR ADVERSE EVENT HAS BEEN REPORTED.