ILLINOIS NEEDLE BONE MARROW 15G ADJ LEN
Received Oct 31, 2017 · Event occurred Oct 12, 2017
Report 9680904-2017-00215 · MDR key 6990185
Device
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Patient Involvement
- Not Applicable
- No Patient Involvement
- Not Applicable
Narrative
Additional Manufacturer Narrative
PR (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.
Additional Manufacturer Narrative
(B)(4). - FOLLOW UP SUBMISSION WILL BE COMPLETED POST INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem
OPEN PACKAGES WERE FOUND DURING INSPECTION CONDUCTED BY BD (B)(4).