BD VACUTAINER® NO ADDITIVE (Z) TUBES
Received Jun 7, 2018 · Event occurred Jul 21, 2016
Report 1917413-2018-02216 · MDR key 7578754
Device
Generic name
Specimen Transport And Storage Container
Manufacturer
Becton, Dickinson & Co.Catalog number
366703
Lot number
UNKNOWN
Product problems
- Incorrect Measurement
- No Device Output
- Incorrect Measurement
- No Device Output
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.
Description of Event or Problem
IT WAS REPORTED THAT THE BD VACUTAINER® NO ADDITIVE (Z) TUBES POWER PROCESSOR WAS HAVING TROUBLE DECAPPING THEIR NON ADDITIVE TUBE (366703). AS A RESULT, THE PROBES WERE CRASHING INTO THE TOP AND CAUSING ANALYZER DOWNTIME. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.