BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE
Received Jun 6, 2018 · Event occurred Nov 7, 2016
Report 2243072-2018-01054 · MDR key 7575406
Device
Generic name
Specimen Transport And Storage Container
Manufacturer
Becton DickinsonCatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Incorrect Or Inadequate Test Results
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE MANUFACTURER: UNKNOWN. BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED. MANUFACTURING LOCATION: UNKNOWN. BD CORPORATE HEADQUARTERS IN (B)(4)HAS BEEN LISTED. 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 BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE HAD "ERRONEOUS RESULTS" NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.