16X125MM 8.0 ML BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE
Received Jul 21, 2017 · Event occurred Jan 27, 2017
Report 1917413-2017-00042 · MDR key 6734494
Device
Generic name
Blood Collection Tube
Manufacturer
Becton, Dickinson & Co.Catalog number
362761
Lot number
6085686
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6085686. 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. NOT CONFIRMED. THREE RETENTION LOT SAMPLES WERE EVALUATED DURING THIS CLINICAL INVESTIGATION. ALL THREE RETENTION AND CONTROL LOT SAMPLES PERFORMED AS EXPECTED AND NO PRODUCT ISSUES WERE OBSERVED DURING THE CLINICAL INVESTIGATION. THIS IS THE FIRST COMPLAINT REPORTED WITH REGARDS THIS LOT NUMBER. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (GLASS BREAKAGE DURING CENTRIFUGATION) MODE BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE CUSTOMER SAMPLES. THIS INCIDENT AND LOT NUMBER WILL BE MONITORED FOR FUTURE OCCURRENCES. THIS COMPLAINT IS NOT CONFIRMED WITH REGARDS TO BREAKAGE DURING CENTRIFUGATION. (B)(4).
Description of Event or Problem
I WAS REPORTED THAT 16 X 125 MM 8.0 ML BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE WERE BREAKING DURING CENTRIFUGATION. NO INJURY OR MEDICAL INTERVENTION.