MONOJECT
Received Nov 29, 2017 · Event occurred Oct 11, 2017
Report 1282497-2017-05497 · MDR key 7069428
Device
Generic name
Needle, Aspiration And Injection, Reusable
Manufacturer
CovidienModel number
8881245164Catalog number
8881245164
Lot number
170300024
Product problems
- Break
- Break
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND WAS CONFIRMED THAT PRODUCTS WERE PRODUCED ACCOMPLISHING QUALITY REQUIREMENTS. TWO USED SAMPLES WERE RECEIVED FOR EVALUATION. THE PRODUCT IS PROVIDED BY AN EXTERNAL SUPPLIER. THE SAMPLES WERE ANALYZED AND A DETACHMENT OF THE DEVICE WAS OBSERVED. THE REPORTED CONDITION IS CONFIRMED. THE ROOT CAUSE HAS BEEN ADDRESSED WITH THE SUPPLIER. ALL THE INVESTIGATION, PREVENTIVE AND CORRECTIVE ACTIONS FOR THIS COMPLAINT WILL BE DOCUMENTED ON A FORMAL CORRECTIVE AND PREVENTATIVE ACTION (CAPA) REQUESTED THROUGH A SUPPLIERS CORRECTIVE ACTION REQUIREMENT (SCAR). A QA ALERT WAS ISSUED AT THE CARDINAL SITE FOR THE INCOMING INSPECTION AREA TO ALERT THEM TO ELEVATE THE INSPECTION PROCESS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
SUBMIT DATE: 11/29/2017. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
THE CUSTOMER REPORTS THAT THE BONE MARROW NEEDLE BROKE DURING A PROCEDURE.