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 the needle broke 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 reported the needle cleanly detached from the hub while in use.The doctor removed the needle from the patient's gums.There was no additional medical intervention or medication required for the patient.
Additional Manufacturer Narrative
Describe event or problem after receiving additional information from the customer, the description has been updated to: the customer reported the needle cleanly detached from the hub while in use.The doctor removed the needle from the patient's gums.There was no additional medical intervention or medication required for the patient.From: the customer reported the needle broke 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.Device updated to: from: detachment of device or device component break.

• 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: 9204991
• Report Number: 1017768-2019-00708
• Device Sequence Number: 2951013
• 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
• Report Date (Section B): 10/24/2019

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
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 10/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other