MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR

Lot Number 150723A

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that two verify v24 scbis yielded positive results.Not all instruments were reprocessed prior to use in patient procedures.The user facility followed their hospital protocol in notifying the patients that were involved in the procedures.No adverse effects have been reported.

Manufacturer Narrative

The user facility followed their hospital protocol in notifying the patients that were involved in the procedures.No adverse effects have been reported.The dhr of the lot number subject of the reported event was reviewed; no issues were noted.Additionally, retains of the lot were tested, and no issues were noted.All cis passed, showing signs of exposure to sterilant.The user facility did not allow steris to inspect the capital equipment, but confirmed it to be operating according to specification.The verify v24 scbi instructions for use to prevent cross contamination states, "caution: always wear gloves when handling the scbi." steris offered in-service training on proper use of the v24 scbi, but the user facility has declined.No additional issues have been reported.

• Brand Name: VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr; mentor OH 44060
• Manufacturer (Section G): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr.; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4899561
• MDR Text Key: 6831775
• Report Number: 3004080920-2015-00013
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 07/08/2015

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: Other
• Device Lot Number: 150723A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/08/2015
• 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
• Patient Outcome(s): Other