MAUDE Adverse Event Report: CARDINAL HEALTH 400 DENTAL NDL 30SH; NEEDLE, DENTAL

Model Number	8881400074
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
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 reports that the caps pop off the syringe in the middle of freezing; will not screw in properly.No patient injury was reported.Additional information received clarified that the issue is not with the cap or the sheath but that the needle is supposed to screw into the syringe but it was not threading or catching properly.There didn¿t seem to be any threading on the needle.The colored end would not stay on the syringe.They are using a miltex syringe self asp 1.8cc metal.This issue occurred during patient use while freezing the patient.It occurred one time.No patient injury or harm.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One box of samples was returned for evaluation.Visual inspections and dimensional testing were performed however the reported issue could not be confirmed as the returned product was within specifications.The investigation analysis did not identify any issues with the manufacturing process that would have caused the reported issue and there were no process deviations found from the dhr review.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 cap not seated on cartridge.The reported lot met all defined acceptance requirements and was released.A specific root cause could not be determined based on the available information and there is no indication of a systemic issue with the product or process, therefore a corrective and preventive action will not be issued at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 400 DENTAL NDL 30SH
• Common Device Name: NEEDLE, DENTAL
• Manufacturer (Section D): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12572482
• Report Number: 1017768-2021-00986
• Device Sequence Number: 3191861
• Product Code: DZM
• UDI-Device Identifier: 10884521002746
• UDI-Public: 10884521002746
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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
• Device Model Number: 8881400074
• Device Catalogue Number: 8881400074
• Device Lot Number: 105307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown