PLASTIC CANNULA HOLDEX STERILE
Received Jul 29, 2020 · Event occurred Jun 2, 2020
Report 8020040-2020-00001 · MDR key 10340938
Device
Generic name
Introduction/drainage Catheter And Accessories
Manufacturer
Greiner Bio-one GmbhModel number
450216Catalog number
450216
Lot number
A19073FK
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(GBO COMPLAINT NUMBER:(B)(4). DETAILS OF CLAIM: WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. BASED ON THE COMPLAINT AND INVESTIGATION REPORT, CUSTOMER SAMPLES AND PICTURES OF THE ACTUAL DEVICE REQUESTED. WE RECEIVED 64PCS OF 450216/A19073FK FOR EVALUATION. THE COMPLAINT IS CONFIRMED AND RECALL WILL BE INITIATED. (RECALL NUMBER 20-220).
Description of Event or Problem
"CUSTOMER STATE THAT SAMPLE BEGAN LEAKING FROM THE SLEEVE COVERING THE NEEDLE INSIDE THE CANNULA AFTER SAMPLE TUBES WERE COLLECTED."
Remedial action
- Recall