DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. RESULT: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR BREAKAGE WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT # 5105880 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER?S INDICATED FAILURE MODE.
D
Patient 1
IT WAS REPORTED THAT 16X125 MM., 8.0 ML. BD VACUTAINER? CPT GLASS MOLECULAR DIAGNOSTICS TUBE. GREEN/RED CONVENTIONAL CLOSURE. SEE THRU LABEL. ADDITIVE: DENSITY GRADIENT POLYMER GEL AND SODIUM HEPARIN FOR MONONUCLEAR CELL PREPARATION, BROKE DURING CENTRIFUGATION. NO INJURY OR MEDICAL INTERVENTION.