JAMSHIDI BONE MARROW BIOPSY
Received Jan 8, 2018 · Event occurred Dec 13, 2017
Report 9680904-2017-00236 · MDR key 7173078
Device
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). FOLLOW UP SUBMISSION WILL BE COMPLETED POST INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
DURING INCOMING VISUAL INSPECTION AT BD (B)(4)- (1 OUT OF 120) PACKAGES WERE FOUND TO BE UNSEALED, THEREFORE STERILITY COMPROMISED.
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. BD IS PERFORMING FURTHER INVESTIGATION ON THIS INTERNAL FINDING. BD WILL CONTINUE TO MONITOR AND PROVIDE FOLLOW UP EMDR AS APPLICABLE.