MAUDE Adverse Event Report: STERIS CORPORATION VERIFY ASSERT SELF-CONTAINED BIOLOGICAL INDICATOR

Lot Number 20211112

Device Problem Leak/Splash (1354)

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

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that the cap foil of the bi was punctured, and no media was present.The reported event is attributed to damage of the foil cap of the biological indicator.This damage may have occurred inadvertently during handling of the scbi by user facility personnel.The verify assert scbi instructions for use state "before use, examine the scbi to ensure that the media-filled cap is not fully seated on the top of the vial and that the foil seal on the cap remains intact.Without removing the cap, examine the bi for evidence of media in the vial.If media is detected in the vial, the seal has been compromised, do not use the bi." steris inspected the retains of the lot number subject of this event and confirmed there was no evidence of damage, and all retains contained media.Additionally, the device history record was reviewed, and no abnormalities were found.No additional issues have been reported.

Event Description

The user facility reported to anvisa their verify assert self-contained biological indicators (scbi) were dry.

• Brand Name: VERIFY ASSERT SELF-CONTAINED BIOLOGICAL INDICATOR
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): STERIS CORPORATION; 9325 pinecone dr; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 9325 pinecone dr.; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 12845004
• MDR Text Key: 281029465
• Report Number: 3004080920-2021-00002
• Device Sequence Number: 1
• Product Code: FRC
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 20211112
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/19/2021
• 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