MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS COMPANY NITROSPRAY PLUS; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	1006060
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was manufactured in 2002 and distributed in 2003.The device's handle has rotated over time due to user error.The handle rotated to cover the pressure release valve so pressure could not be released.The pressure build up caused the cap to be ejected from the container.
Event or Problem Description
Nitrospray unit was filled and sitting on the counter and the lid blew off.Ceiling damage, their maintenance staff fixed it immediately, no other damage or injury reported.Event occurring 8:05am (b)(6) 2022.

• Brand Name: NITROSPRAY PLUS
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 19462
• Manufacturer (Section G): PREMIER MEDICAL MANUFACTURING; 10090 sandmeyer ln; philadelphia PA 19116
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 2156769090
• MDR Report Key: 13713565
• Report Number: 2511556-2022-00002
• Device Sequence Number: 5956941
• Product Code: GEH
• UDI-Device Identifier: D6911006060
• UDI-Public: D6911006060
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K970992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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: 1006060
• Device Catalogue Number: 1006060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2002
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown