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	11/09/2017
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.
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.

• 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: 7064542
• Report Number: 1282497-2017-05486
• Device Sequence Number: 13648891
• 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: 11/28/2017
• Supplement Report FDA Received Date: 02/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other