ILLINOIS NEEDLE BONE MARROW 15G ADJ LE
Received Jan 31, 2020 · Event occurred Jan 6, 2020
Report 9680904-2020-00003 · MDR key 9654553
Device
Generic name
Tray, Surgical, Needle
Manufacturer
Carefusion, IncCatalog number
DIN1515X
Lot number
0001314966
Product problems
- Unsealed Device Packaging
- Unsealed Device Packaging
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4) -FOLLOW UP EMDR FOR DEVICE EVALUATION. FOUR PHOTO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THREE OF THE PHOTOS POINT TO WHERE THE FAILURE OCCURRED AND A HOLE IN THE POUCHES CAN BE OBSERVED. BASED ON THE INSPECTION PERFORMED, THE FAILURE MODE COULD BE CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR ITS RELEASE WERE MET. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT HAS NOT YET BEEN DETERMINED. A PROJECT HAS BEEN OPENED TO FURTHER INVESTIGATE AND ADDRESS THIS INCIDENT. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.
Description of Event or Problem
DAMAGED/DEFECTIVE SEAL.
Additional Manufacturer Narrative
(B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem
DAMAGED/DEFECTIVE SEAL.
Remedial action
- Other