MAUDE Adverse Event Report: COVIDIEN 401 DENTAL NDL 27LG; NEEDLE, DENTAL

Model Number	8881401056
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2019
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 needles are falling apart and not staying together, one needle got stuck on the patient's cheek.Additional information received from the customer stated that the doctor used his right hand to inject the anesthetic and when the needle got separated from the metal hub, he grabbed the hub part and pulled it out.The patient was not aware the incident happened.
Additional Manufacturer Narrative
A device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.There were 200 (unopened, unused) samples returned with the complaint.A total of 80 samples were randomly selected for functional testing.The samples were physically tested using the test method for needle assembly pull test.The purpose of this test method is to provide instruction for the method used to verify the strength of the cannula-to-hub bond for needles assembled using either epoxy/adhesive or mechanical crimp to secure the cannula.All samples passed the testing.The reported condition could not be replicated or confirmed.An exact root cause for the reported condition was not identified but may occur during use.The instructions for use require the user to perform an injection according to local standard procedures.Insufficient evidence is available to indicate the issue was a result of user error.Based on the information available, this potential root cause could not be confirmed or discarded from consideration.At this time, there is no trending or information that would trigger the need to initiate a corrective/preventative action (capa).

• Brand Name: 401 DENTAL NDL 27LG
• Common Device Name: NEEDLE, DENTAL
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8981433
• Report Number: 1017768-2019-00678
• Device Sequence Number: 3330055
• Product Code: DZM
• UDI-Device Identifier: 30884521002863
• UDI-Public: 30884521002863
• 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): 11/26/2019

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?: Yes
• Operator of Device: No Information
• Device Model Number: 8881401056
• Device Catalogue Number: 8881401056
• Device Lot Number: 913341
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 11/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other