ILLINOIS NEEDLE BONE MARROW BIOPSY
Received Dec 20, 2017 · Event occurred Nov 27, 2017
Report 9680904-2017-00231 · MDR key 7134994
Device
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
PR (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
DURING INSPECTION, BD (B)(4) CONFIRMED THAT 122 PRODUCTS OUT OF 2740 WEREN'T SEALED PROPERLY THEREFORE COMPROMISING STERILITY.
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.