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

Model Number 8881245164

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/12/2018.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 needle broke.The customer further reports that no medical or surgical intervention was needed as a result and there was no injury to the patient.

Manufacturer Narrative

An investigation of the reported condition was performed.Since the lot number was not provided by the customer therefore a review of device history record (dhr) could not been performed.No samples were provided for evaluation.Therefore, the reported condition could not be confirmed.However, based on recently received complaints for the same part number and similar reported issue, the possible root cause may be related to the supplier¿s manufacturing process.All the corrective actions and preventative actions (capa) will be documented through a suppliers corrective action report (scar) and capa report.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 almeidqa ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7186354
• MDR Text Key: 97106467
• Report Number: 9610849-2018-00002
• Device Sequence Number: 1
• Product Code: GDM
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881245164
• Device Catalogue Number: 8881245164
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1