JAMSHIDI BONE MARROW BIOPSY
Received Dec 19, 2017 · Event occurred Nov 24, 2017
Report 9680904-2017-00233 · MDR key 7128863
Device
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Information
- No Information
Narrative
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.
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
¿DURING INCOMING VISUAL INSPECTION AT BD (B)(4) - (1 OUT OF 130) PACKAGES WERE FOUND TO BE UNSEALED, THEREFORE STERILITY COMPROMISED.¿