BD VACUTAINER® URINE COLLECTION CUPS
Received Aug 29, 2019 · Event occurred Aug 9, 2019
Report 1917413-2019-01990 · MDR key 8944916
Device
Generic name
Specimen Transport And Storage Container
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
364975
Lot number
UNKNOWN
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT LABEL ERROR OCCURRED BEFORE USE WITH BD VACUTAINER® URINE COLLECTION CUPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE USE AND DISTRIBUTE AT A HIGH VOLUME YOUR PRODUCT # 364975 WHICH IS A URINE CONTAINER WITH TRANSFER DEVICE. WE HAVE JUST RECEIVED A COMPLAINT THAT THE LABEL (CAUTION) ON THE PRODUCT WOULD ONLY BE IN ENGLISH." AS PER THEIR CONTRACT WE SHOULD PICTOGRAPH OR HAVE BILINGUAL LABELS. "
Additional Manufacturer Narrative
INVESTIGATION: 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.
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT LABEL ERROR OCCURRED BEFORE USE WITH BD VACUTAINER® URINE COLLECTION CUPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE USE AND DISTRIBUTE AT A HIGH VOLUME YOUR PRODUCT # 364975 WHICH IS A URINE CONTAINER WITH TRANSFER DEVICE. WE HAVE JUST RECEIVED A COMPLAINT THAT THE LABEL (CAUTION) ON THE PRODUCT WOULD ONLY BE IN ENGLISH." AS PER THEIR CONTRACT WE SHOULD PICTOGRAPH OR HAVE BILINGUAL LABELS. "