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

Model Number	8881245164
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 12/26/2017.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 states that the needle separated or broke off where it attached to the handle when it was being removed.
Additional Manufacturer Narrative
The report refers to product code 8881245164 illinois sternal-illiac needle with lot number 170300024.A device history record (dhr) was reviewed and was confirmed that products were produced accomplishing quality requirements no non-conformance reports (ncr)¿s were found it.One used sample was received at the manufacturing site.Because the product is provided by an external supplier the samples were analyzed; during the evaluation a detachment of the needle was visual.The reported condition is confirmed.The root cause is related with the manufacturing process of the supplier.All the investigation, preventive and corrective actions for this complaint will be documented on a formal supplier corrective action report and corrective/preventative action (capa).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; 37 boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 7158428
• Report Number: 1282497-2018-00009
• Device Sequence Number: 140384
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 03/01/2018
• Patient Sequence Number: 1