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

Lot Number HC3450W2, HC2810R9

Device Problem Leak/Splash (1354)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

Following notification of the reported event, steris quality requested that the cup subject of the event be returned for evaluation.Upon receipt, three cups were returned to steris (1 cup from lot number hc3450w2 and 2 cups from lot number hc2810r9).The returned cups were evaluated by steris and no issues with the welds for the lid were identified.No leaking was observed.Steris performed retain testing and confirmed there was no evidence of damage or leaking cups.Additionally, the device history records were reviewed and confirmed the lots were manufactured to specification; no abnormalities were identified.There have been no other complaints associated with these lots.No additional issues have been reported.

Event Description

The user facility reported to anvisa that vaprox sterilant was observed leaking into the packaging bag that holds the sterilant cup.No report of injury or procedure delay.

• 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: 12565005
• MDR Text Key: 274484114
• Report Number: 3003950207-2021-00006
• Device Sequence Number: 1
• Product Code: MLR
• 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
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: HC3450W2, HC2810R9
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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