ILLINOIS NEEDLE BONE MARROW 15G ADJ LEN
Received Oct 25, 2017 · Event occurred Sep 27, 2017
Report 9680904-2017-00214 · MDR key 6978249
Device
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(6). A SUPPLEMENT MDR WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem
THE PACKAGES WERE UNSEALED DURING VISUAL INSPECTION AT (B)(6).
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.