MAUDE Adverse Event Report: IVOCLAR VIVADENT AG VIVAPEN SNAP-ON CANNULAS REFILL; SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Model Number	745762
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was due to the loose fit of the cannulas, which were caused by production issues.Appropriate quality measures & production controls were implemented to correct irregularities.The users of the affected devices are being informed of the risk and how to minimize it.
Event or Problem Description
A doctor reported that cannulas were falling into multiple patients mouth due to fit issues.The doctor did not indicate that any patients were injured.

• Brand Name: VIVAPEN SNAP-ON CANNULAS REFILL
• Common Device Name: SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
• Manufacturer (Section D): IVOCLAR VIVADENT AG; bendererstrasse 2; schaan, 9494 ; LS 9494
• Manufacturer Contact: robert streber ; 175 pineview drive; amherst, NY 14228 ; 7162642045
• MDR Report Key: 15824484
• Report Number: 9612352-2022-00002
• Device Sequence Number: 20372317
• Product Code: EID
• UDI-Device Identifier: DVIV7457621
• UDI-Public: DVIV7457621
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: 745762
• Device Catalogue Number: 745762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown