MAUDE Adverse Event Report: COVIDIEN 400 DENTAL NDL 30SH; NEEDLE, DENTAL

Model Number 8881400074

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reports: while injecting an anesthetic into the patient, the tip of the needle broke off into the patient's gum.The patient was sent to the hospital and had to go to oral surgery to remove the tip.The tip has been removed and the patient is doing ok.

Manufacturer Narrative

No lot number was provided.A review of the device history record (dhr) was unable to be performed.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The complaint file contains insufficient information to determine a specific root cause.The reported complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.

• Brand Name: 400 DENTAL NDL 30SH
• Type of Device: NEEDLE, DENTAL
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7966222
• MDR Text Key: 123735927
• Report Number: 1017768-2018-00510
• Device Sequence Number: 1
• Product Code: DZM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8881400074
• Device Catalogue Number: 8881400074
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention