MAUDE Adverse Event Report: STERIS CORPORATION - DISTRIBUTION CENTER VAPROX STERILANT

Model Number PB011

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2022

Event Type  malfunction  

Event Description

The user facility reported to anvisa that their vpro max 2 sterilizer did not recognize a vaprox hc sterilant cup upon insertion.The user facility then inserted a different vaprox hc sterilant cup from the same lot and no issues were noted.No report of injury.

Manufacturer Narrative

Following notification of the reported event, steris quality requested that the cup subject of the event be returned for evaluation.The investigation of the subject event is in process.A follow-up mdr will be submitted when additional information becomes available.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the vpro max 2 sterilizer and found the unit to be operating properly.No repairs were required, and the unit was returned to service.The cup subject of the event was not returned for evaluation.Without a returned cup, the root cause cannot be determined.The device history records was reviewed and confirmed that the lot was manufactured to specification; no abnormalities were found.There have been no other complaints associated with this lot.No additional issues have been reported.

• Brand Name: VAPROX STERILANT
• Type of Device: STERILANT
• Manufacturer (Section D): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14578391
• MDR Text Key: 301240944
• Report Number: 3003950207-2022-00001
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 00724995153090
• UDI-Public: 00724995153090
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PB011
• Device Catalogue Number: PB011
• Device Lot Number: HC2101P7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1