MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS VERIFY CHALLENGE PACK

Lot Number 029862

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

The user facility processed a load in their sterilizer with a verify challenge pack and did not realize the biological indicator (bi) was missing until the cycle had already completed.The user facility reprocessed the instruments present with a new verify challenge pack prior to use in patient procedures.The lot number provided in the medwatch report is not a lot number manufactured by steris.A follow-up mdr will be submitted should additional information become available.

Event Description

The user facility reported via medwatch report mw5070941 that their verify challenge pack did not contain a biological indicator (bi).

Manufacturer Narrative

Steris has confirmed per further discussion with the user facility that this product and specific lot number was manufactured by steris.The dhr was reviewed and no abnormalities were found.No additional issues have been reported.

• Brand Name: VERIFY CHALLENGE PACK
• Type of Device: VERIFY CHALLENGE PACK
• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 6816984
• MDR Text Key: 83749208
• Report Number: 3004080920-2017-00008
• 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,Followup
• Report Date: 08/24/2017

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: No Information
• Device Lot Number: 029862
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 11/01/2017
• 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