MAUDE Adverse Event Report: COVIDIEN 30 G SHORT PLASTIC; DENTAL NEEDLE

Model Number 8881400074

Device Problems Detachment Of Device Component (1104); Defective Component (2292)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway; upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dental needle.The customer states the needles are defective because the metal parts separate from the tips, and fall to the ground.

Manufacturer Narrative

An investigation of the reported condition was performed.The review of device history record (dhr) indicates that no issues were found for the reported lot.The review of maintenance and calibration records, machine set up, process monitoring data detected no issues.All scheduled maintenance and calibration activities were completed on time.There were no process or material changes that have occurred for the reported condition.The current state of the machine was found to be operating normally.The samples were not returned for evaluation.The reported condition could not be confirmed.Should the sample be returned, the compliant can be reopened.The exact root cause of the reported condition could not be determined without an actual sample.With the little evidence available, the most probable root cause could not be determined as well.Prior to a lot release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, visual inspection is performed for correct assembly and pull tested for cannula to hub security.The lot released met all defined acceptance requirements.No corrective and preventive actions are deemed necessary now.This information will be utilized for trending purposes to determine the need for corrective actions.The production department will be notified about incident with a copy of this complaint response.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 30 G SHORT PLASTIC
• Type of Device: DENTAL NEEDLE
• Manufacturer (Section D): COVIDIEN; 2010 east international speedway blvd.; deland FL 32720
• Manufacturer (Section G): COVIDIEN; 2010 east international speedway blvd.; deland FL 32720
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6073157
• MDR Text Key: 59349300
• Report Number: 1017768-2016-00099
• Device Sequence Number: 1
• Product Code: EJI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8881400074
• Device Catalogue Number: 8881400074
• Device Lot Number: 529921
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1