JAMSHIDI NEEDLE BONE MARROW
Received Oct 30, 2018 · Event occurred Oct 9, 2018
Report 9680904-2018-00026 · MDR key 8019340
Device
Generic name
Biopsy Needles & Trays
Manufacturer
Carefusion, IncCatalog number
DJ4011X
Lot number
0001220841
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4) UPON COMPLETION OF CAREFUSIONS INVESTIGATION A FOLLOW UP SUBMISSION WILL BE COMPLETED.
Description of Event or Problem
UPON INSPECTION OF OUR QC PERSONNEL AND PLACEMENT OF REGULATORY LABEL TO EACH ITEMS, 5 CASES OF (B)(4) CONTAIN ITEMS WITH DEFECTIVE SEAL.
Additional Manufacturer Narrative
(B)(4) OUR QUALITY ENGINEERS RECEIVED EIGHT PHOTOS FOR EVALUATION. DURING VISUAL EVALUATION, IT WAS DETERMINED ALL NINETEEN (19) POUCHES WERE OPENED ON THE SIDES, THEREFORE, FAILURE MODE COULD BE CONFIRMED. ALTHOUGH REPORTED FAILURE WAS CONFIRMED THROUGH VISUAL ANALYSIS A ROOT CAUSE COULD NOT BE DETERMINED THROUGH THIS INVESTIGATION. TO FURTHER INVESTIGATE ROOT CAUSE, BD HAS INITIATED A CAPA. THE FAILURE MODE WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM TO BE TRACKED/TRENDED. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS DURING OUR QUALITY TEAM MEETING.
Description of Event or Problem
UPON INSPECTION OF OUR QC PERSONNEL AND PLACEMENT OF REGULATORY LABEL TO EACH ITEMS, 5 CASES OF DJ4011X CONTAIN ITEMS WITH DEFECTIVE SEAL.