JAMSHIDI NEEDLE BONE MARROW 8GX4 ASP
Received Oct 22, 2018 · Event occurred Sep 1, 2018
Report 9680904-2018-00023 · MDR key 7990509
Device
Generic name
Biopsy Needles & Trays
Manufacturer
Carefusion, IncCatalog number
DJ4008X
Lot number
0001240515
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
PR 589627 OUR MANUFACTURING QUALITY ENGINEER RECEIVED EIGHT PHOTOS (8) FOR EVALUATION. IT COULD BE SEEN THAT THE POUCHES ARE OPEN ON THE SIDES, THEREFORE, FAILURE MODE COULD BE CONFIRMED. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED FOR THE REPORTED LOT NUMBERS MANUFACTURED CONFIRMING PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEED FOR THE PRODUCT TO BE RELEASED WERE MET. ALTHOUGH REPORTED FAILURE WAS CONFIRMED THROUGH VISUAL ANALYSIS A ROOT CAUSE COULD NOT BE DETERMINED THROUGH THIS INVESTIGATION. AS A RESULT A CAPA HAS BEEN INITIATED.
Description of Event or Problem
THE SEAL IS OPEN PARTIALLY ON THE PRODUCT POUCH.
Additional Manufacturer Narrative
(B)(4). FOLLOW UP SUBMISSION WILL BE COMPLETED POST INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE SEAL IS OPEN PARTIALLY ON THE PRODUCT POUCH.