MAUDE Adverse Event Report: COVIDIEN MONOJECT; NEEDLE, ASPIRATION AND INJECTION, REUSABLE

Model Number	8881245164
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The customer reports that the bone marrow needle broke during a procedure.
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.

• Brand Name: MONOJECT
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, REUSABLE
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 7069428
• Report Number: 1282497-2017-05497
• Device Sequence Number: 1068644
• Product Code: GDM
• UDI-Device Identifier: 20884521020471
• UDI-Public: 20884521020471
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 8881245164
• Device Catalogue Number: 8881245164
• Device Lot Number: 170300024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 02/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other