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

Model Number	8881401072
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
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 the needle broke during a procedure.
Additional Manufacturer Narrative
Evaluation summary the device history record (dhr) for the reported lot indicates no issues were found in visual and physical samples inspected from the lot.There were no non conformance reports (ncr) issued against this lot.A review of the entire dhr did not identify any manufacturing or inspection anomalies.There were 71 unused samples returned for evaluation.The box of samples containing the needles was already open.Samples were randomly selected for the cannula pull test per procedure.All samples passed inspection.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.The investigation did not identify a systemic issue with the product or process.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.This complaint will be used for trending purposes.

• 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: 9664284
• Report Number: 1017768-2020-00786
• Device Sequence Number: 19466795
• 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): 04/13/2020

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: 8881401072
• Device Catalogue Number: 8881401072
• Device Lot Number: 926628
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1