MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX INTERNATIONA SPORVIEW; INDICATOR, BIOLOGICAL STERILIZATION PROCESS

Catalog Number SBT-025

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operational Issue (2914)

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

Event Date 09/24/2016

Event Type  malfunction  

Event Description

The biologic indicator was placed in the sterilizer as directed by the product manufacturer (placed in an unopened box).The indicator was then sent to the lab (per protocol) for incubation.It failed the test and it was noted that the vial was dried out where it normally has liquid medium in it.The lot numbers of the product in question were pulled.

• Brand Name: SPORVIEW
• Type of Device: INDICATOR, BIOLOGICAL STERILIZATION PROCESS
• Manufacturer (Section D): SPSMEDICAL SUPPLY CORP. A DIVISION OF CROSSTEX INTERNATIONA; 6789 w. henrietta road; rush NY 14543
• MDR Report Key: 6112603
• MDR Text Key: 60348162
• Report Number: 6112603
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: SBT-025
• Device Lot Number: 2082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO