BIO 701 CONTAINER WITH INSULATION
Received Dec 7, 2017 · Event occurred Dec 10, 2015
Report 2243072-2017-00309 · MDR key 7095536
Device
Product problems
- Difficult to Open or Close
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT # UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; UNIQUE IDENTIFIER (UDI) # UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEFECT COULD NOT BE CONFIRMED FROM THE PHOTO. 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.
Description of Event or Problem
IT WAS REPORTED THAT BIO 701 CONTAINER WITH INSULATION HAD LOCKS THAT WOULDN'T CLOSE CORRECTLY, THEY SEE TO GET LOOSE AND THE CONTAINER CAN NOT BE CLOSED. NO INJURY OR MEDICAL INTERVENTION REPORTED.