ILLINOIS NEEDLE BONE MARROW BIOPSY
Received Nov 27, 2017 · Event occurred Nov 2, 2017
Report 9680904-2017-00224 · MDR key 7061291
Device
Product problems
- Unsealed Device Packaging
- Device Disinfection Or Sterilization Issue
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). A FOLLOW UP SUBMISSION WILL BE DONE UPON COMPLETION OF CAREFUSION'S INVESTIGATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
MARK OF SEALING ON THE PACKAGES WAS CONFIRMED BUT THEY WEREN'T SEALED PROPERLY. ON 22NOV2017 ADDITIONAL INFORMATION- THIS COMPLAINT IS OPEN PACKAGE ISSUE THAT AFFECTS THE STERILIZATION OF THE ITEM.
Additional Manufacturer Narrative
(B)(4) UPON FURTHER EVALUATION IT HAS BEEN DETERMINED THIS EVENT DID NOT MEET THE REQUIREMENTS FOR EMDR REPORTING. AS THE ISSUE REPORTED WAS FOUND AND RECEIVED WHILE PRODUCT WAS STILL IN CONTROL OF BD. TO DATE, BD HAS NOT RECEIVED ANY FURTHER REPORTS FROM DIRECT CUSTOMERS WITH THIS FAILURE. BD IS PERFORMING FURTHER INVESTIGATION ON THIS INTERNAL FINDING. BD WILL CONTINUE TO MONITOR AND PROVIDE FOLLOW UP EMDR AS APPLICABLE.