MAUDE Adverse Event Report: 400 DENTAL NDL 27LG; NEEDLE, DENTAL

Model Number	8881400058
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
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 when screwing the needle into the syringe, the needle is loose and wobbles.
Additional Manufacturer Narrative
The device history record (dhr) review found that there were no related issues recorded throughout the manufacturing and control processes.The product was in conformance to specifications and was released for distribution meeting all established quality assurance acceptance levels.There were 97 samples returned to the manufacturing site for evaluation.The samples were visually inspected and the design of this needle, per the bill of material does not have threaded hubs.The hub drawing was reviewed, and this dental hub has four (4) ribs inside the luer that allow the hub to connect to the syringe luer tip.The samples were physically tested by attaching them into a dental syringe.All samples were securely attached to the dental syringe.The reported condition could not be confirmed.The exact root cause could not be determined based on the available information.The investigation analysis did not identify any issues with the manufacturing process that would have caused the reported issue.Based on this analysis, there is the possibility the hubs had some sort of issue, but because no specific details were found through the investigation, it is not certain if these were the cause of the failure found by the customer.Per the sample analysis, the reported condition could not be confirmed.A 6m root cause investigation was conducted and reviewed multiple contributing factors.The application of the device could not be verified from the information present in the complaint.Prior to a lot¿s release, the lot must be deemed acceptable, 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 product/components (functional but less than desired), and damaged product/components (non-functional).The lot met all defined acceptance requirements and was released.The investigation did not identify a systemic issue or trend with the product or process therefore, a corrective and preventive action (capa) is not necessary.Further analysis will be performed to track and trend any adverse results.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 400 DENTAL NDL 27LG
• Common Device Name: NEEDLE, DENTAL
• MDR Report Key: 11815734
• Report Number: 1017768-2021-00940
• Device Sequence Number: 3686366
• Product Code: DZM
• UDI-Device Identifier: 20884521002620
• UDI-Public: 20884521002620
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 8881400058
• Device Catalogue Number: 8881400058
• Device Lot Number: 028635
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 09/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: N
• Patient Sequence Number: 1