MAUDE Adverse Event Report: COVIDIEN 401 DENTAL NDL 30SH; NEEDLE, DENTAL

Model Number	8881401072
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
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.Additional information received from the customer on 30-aug-2019 stated that the needles are falling apart at the metal hub during use.No patient injury reported.
Additional Manufacturer Narrative
A review of the device history records (dhrs) for the probable lot number 903518 (communicated by the customer) indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.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.There were 100 (unopened, unused) and 300 (opened, unused) samples returned with the complaint.Functional testing of 80 samples were physically tested per product specification.The test method used was the needle assembly pull test.The purpose of this test 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 confirmed.There were no manufacturing issues related to the complaint issued for this lot and a specific root cause could not be determined based on the available information.The exact nature of the alleged condition 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.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 401 DENTAL NDL 30SH
• Common Device Name: NEEDLE, DENTAL
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8977860
• Report Number: 1017768-2019-00677
• Device Sequence Number: 335623
• Product Code: DZM
• UDI-Device Identifier: 10884521002906
• UDI-Public: 10884521002906
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8881401072
• Device Catalogue Number: 8881401072
• Device Lot Number: 903518
• 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: 09/09/2019
• Supplement Report FDA Received Date: 11/21/2019
• Patient Sequence Number: 1