ILLINOIS NEEDLE BONE MARROW
Received Feb 16, 2018 · Event occurred Jan 17, 2018
Report 9680904-2018-00002 · MDR key 7277593
Device
Generic name
Biopsy Needles & Trays
Manufacturer
Carefusion, IncCatalog number
DIN1515X
Lot number
0000919888
Product problems
- Packaging Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). A FOLLOW UP EMDR SUBMISSION WILL BE COMPLETED UPON COMPLETION OF INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
LABELING ABNORMALITY ON 11 NEEDLES FOR STERNAL PUNCTURE OF THE SAME LOT. THE STATED EXPIRY DATE IS 27/02/2021 AND THE MANUFACTURING DATE OF 30/03/2030.
Additional Manufacturer Narrative
(B)(4) OUR QUALITY ENGINEERS RECEIVED ONE PHOTO FROM LOT #0000919888 FOR EVALUATION. FAILURE MODE COULD BE CONFIRMED SINCE THE MANUFACTURING DATE PRINTED WAS INCORRECT ACCORDING TO PRODUCT CODE/BATCH. THE INVESTIGATION CONCLUDED THE ROOT CAUSE COULD BE RELATED TO THE MANUFACTURING PROCESS AND METHODS. WE HAVE SINCE OPENED UP A CAPA AND DURING THE SAMPLING REVIEW PROCESS, BD VERIFIED THE EXPIRATION AND MANUFACTURING DATE ON LABELS WERE ACCURATE. THE FAILURE MODE WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED / TRENDED FOR ANY ADDITIONAL SIMILAR FAILURE MODES. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS DURING OUR QUALITY TEAM MEETING. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.