MEDEX TRANSTAR BLOOD SAMPLE KIDS KIT

Additional Manufacturer Narrative

H2) DEVICE EVALUATION: H3, H6: TWENTY-FIVE DEVICES WERE RETURNED FOR ROOT CAUSE ANALYSIS AND THE INVESTIGATION FINDINGS CONCLUDED AFTER VISUAL INSPECTION AND FUNCTIONAL TESTING, THE CUSTOMER PROBLEM WAS NOT DUPLICATED. THE DEVICE HAD NEITHER LEAK CONDITION NOR AIR IN THE LINE WAS OBSERVED DURING TESTING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURING.

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.