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

Model Number 8881245164

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2017

Event Type  Injury  

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 Description

The customer reports that the bone marrow needle broke during a procedure.

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
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, REUSABLE
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7069428
• MDR Text Key: 93281633
• Report Number: 1282497-2017-05497
• Device Sequence Number: 1
• Product Code: GDM
• UDI-Device Identifier: 20884521020471
• UDI-Public: 20884521020471
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other