MONOJECT
Received Nov 28, 2017 · Event occurred Nov 9, 2017
Report 1282497-2017-05486 · MDR key 7064542
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
THE REPORT REFERS TO PRODUCT CODE 8881245164 ILLINOIS STERNAL-ILLIAC NEEDLE WITH LOT NUMBER 170300024. A DEVICE HISTORY RECORD WAS REVIEWED AND WAS CONFIRMED THAT PRODUCTS WERE PRODUCED ACCOMPLISHING QUALITY REQUIREMENTS NO NON-CONFORMANCE REPORTS (NCR)S WERE FOUND IT. NO SAMPLES WERE PROVIDED FOR EVALUATION, THE PREVENTIVE AND CORRECTIVE ACTIONS FOR THIS COMPLAINT WILL BE DOCUMENTED ON A FORMAL CORRECTIVE/PREVENTATIVE ACTION (CAPA). A QA ALERT WAS ISSUED AT THE MANUFACTURING FACILITY FOR THE INCOMING INSPECTION AREA. 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: 11/28/2017. 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 ASPIRATE NEEDLE BROKE OFF IN THE PATIENT'S ILIAC CREST DURING A PROCEDURE. FORCEPS WERE USED TO PULL OUT THE BROKEN PIECE.