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

Model Number	8881400074
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the needle tip broke while in use.The doctor removed the broken tip from the patient's gums.There was no additional medical intervention or medication required for the patient.
Event or Problem Description
The customer stated the needle cleanly detached from the hub while in use.The doctor removed the broken tip from the patient's gums.There was no additional medical intervention or medication required for the patient.
Additional Manufacturer Narrative
Additional information was received from the customer.Describe event or problem has been updated to: the customer stated the needle cleanly detached from the hub while in use.The doctor removed the broken tip from the patient's gums.There was no additional medical intervention or medication required for the patient.From: the customer reported that the needle tip broke while in use.The doctor removed the broken tip from the patient's gums.There was no additional medical intervention or medication required for the patient.
Additional Manufacturer Narrative
The device history record (dhr) for lot 832343 indicates that there were not any manufacturing or inspection anomalies related to the customer complaint.There were no samples returned with the complaint, but a photograph was submitted with the complaint.The photograph was inspected and shows an open box of dental needles for lot 832343.All visible needles seem to still be enclosed in their hard pack container and there is no indication of the reported condition.Physical samples are required to determine if the needles are detaching from the hub or not.The reported condition is not confirmed based on the pictures provided in the complaint.There were no manufacturing issues related to the complaint issued for this lot and a specific root cause could not be determined based on available information.The exact nature of the alleged defect could not be determined.The possible root causes identified in this complaint pertain to the user¿s application of the device.It¿s recommended the user consult the instructions for use for more information.Since there were no findings related to the reported condition, no corrective actions are required at this time.

• Brand Name: 400 DENTAL NDL 30SH
• Common Device Name: NEEDLE, DENTAL
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9204764
• Report Number: 1017768-2019-00706
• Device Sequence Number: 14229780
• Product Code: DZM
• UDI-Device Identifier: 10884521002746
• UDI-Public: 10884521002746
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2020

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?: No
• Operator of Device: No Information
• Device Model Number: 8881400074
• Device Catalogue Number: 8881400074
• Device Lot Number: 832343
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019; 10/08/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 10/24/2019; 01/07/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other