MEDEX TRANSTAR BLOOD SAMPLE KIDS KIT

Additional Manufacturer Narrative

B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE TUBING WAS CRACKED, RESULTING IN AIR IN THE LINE AND LEAKAGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

CORRECTED : D3 - MFG ESTABLISHMENT NAME AND G1 - CONTACT OFFICE ESTABLISHMENT NAME 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.