MONOJECT
Received Jan 12, 2018
Report 9610849-2018-00002 · MDR key 7186354
Device
Generic name
Needle, Aspiration And Injection, Reusable
Manufacturer
CovidienModel number
8881245164Catalog number
8881245164
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 01/12/2018. 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 NEEDLE BROKE. THE CUSTOMER FURTHER REPORTS THAT NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED AS A RESULT AND THERE WAS NO INJURY TO THE PATIENT.
Additional Manufacturer Narrative
AN INVESTIGATION OF THE REPORTED CONDITION WAS PERFORMED. SINCE THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER THEREFORE A REVIEW OF DEVICE HISTORY RECORD (DHR) COULD NOT BEEN PERFORMED. NO SAMPLES WERE PROVIDED FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. HOWEVER, BASED ON RECENTLY RECEIVED COMPLAINTS FOR THE SAME PART NUMBER AND SIMILAR REPORTED ISSUE, THE POSSIBLE ROOT CAUSE MAY BE RELATED TO THE SUPPLIER¿S MANUFACTURING PROCESS. ALL THE CORRECTIVE ACTIONS AND PREVENTATIVE ACTIONS (CAPA) WILL BE DOCUMENTED THROUGH A SUPPLIERS CORRECTIVE ACTION REPORT (SCAR) AND CAPA REPORT. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.