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

Model Number	8881401072
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
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 the needles come off when taking the cap off.There was no harm to the patient.
Additional Manufacturer Narrative
An investigation of the reported condition was performed.The device history record (dhr) for the lot indicates no issues were found in visual and physical samples inspected.Unopened and unused samples were returned for evaluation.Samples were randomly selected for visual and functional testing.After visual inspection, no issues were found.None of the hub-needle assemblies fell once the cap was removed from the needle.Samples were also physically tested to determines if the cannula is properly secured in the hub of the needle.All samples passed the testing.The reported condition could not be confirmed.The exact root cause could not be determined based on available information.The investigation analysis did not identify any issues with the manufacturing process that would have caused this issue.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 corrective and preventative action (capa) will not be issued 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: 8637355
• Report Number: 1017768-2019-00644
• Device Sequence Number: 16662269
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1