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

Model Number	8881401171
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
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 item doesn't fit on the syringe.
Additional Manufacturer Narrative
A device history record confirmed that the product was produced accomplishing quality requirements and released according to established procedures.There were four (unopened) unit boxes returned for this complaint.All samples were visually inspected, specifically for any damage in the luer and deformities of the hub.All samples passed inspection and no deviations were found.The reported condition could not be confirmed.The exact root cause could not be determined based on the returned samples.The investigation analysis did not identify any issues with the manufacturing process that would have caused this issue.A 6m root cause investigation was conducted and reviewed for potential contributing factors.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for damaged components and poor workmanship.The lot met all defined acceptance criteria and was released.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.There¿s no indication of a systemic issue with the product or process, so a formal corrective/preventative action will not be issued at this time.This complaint will be used for trending purposes.

• Brand Name: 401 DENTAL NDL 30 XS
• Common Device Name: NEEDLE, DENTAL
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 10474705
• Report Number: 1017768-2020-00853
• Device Sequence Number: 2889614
• Product Code: DZM
• UDI-Device Identifier: 10884521010420
• UDI-Public: 10884521010420
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 8881401171
• Device Catalogue Number: 8881401171
• Device Lot Number: 000671
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 11/06/2020
• Patient Sequence Number: 1