JAMSHIDI BONE MARROW BIOPSY
Received Nov 1, 2017 · Event occurred Oct 12, 2017
Report 9680904-2017-00220 · MDR key 6993292
Device
Product problems
- Break
- Unsealed Device Packaging
- Break
Patient
NA · Unknown
- Not Applicable
- No Clinical Signs, Symptoms or Conditions
- Not Applicable
- No Clinical Signs, Symptoms or Conditions
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
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED IN RESPONSE TO FDA CORRESPONDENCE INDICATING THAT SUPPLEMENTAL REPORT 1 WAS NOT RECEIVED FOR THIS EVENT. UPON FURTHER INTERNAL ASSESSMENT, IT WAS DETERMINED THAT IN 2017, A REVIEW WAS CONDUCTED WHICH CONCLUDED THAT THE EVENT DID NOT MEET MDR REPORTING CRITERIA AT THAT TIME, AS THE PRODUCT REMAINED UNDER BD¿S CONTROL AND HAD NOT BEEN DISTRIBUTED TO CUSTOMERS. HOWEVER, TO ENSURE ALIGNMENT WITH CURRENT REGULATORY EXPECTATIONS AND TO ADDRESS THE FDA¿S REQUEST, BD IS SUBMITTING THIS CORRECTIVE SUPPLEMENTAL REPORT.
Description of Event or Problem
OPEN PACKAGES WERE FOUND DURING INSPECTION CONDUCTED BY BD JAPAN.
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).