MAUDE Adverse Event Report: 3M HEALTH CARE 3M ATTEST SUPER-RAPID READOUT BIOLOGICAL INDICATOR; INDICATOR, BIOLOGICAL STERILIZATION

Catalog Number 1492V

Device Problem Material Fragmentation (1261)

Patient Problem Infiltration into Tissue (1931)

Event Date 08/09/2014

Event Type  Injury  

Event Description

The supervisor in the sterile processing department reported that a male employee, used a 3m attest super-rapid readout biological indicator.The man removed the vial from the sterilizer, let the vial cool, and placed it into the reader.When the male employee pushed down on the attest vial with his thumb, a piece of "something" allegedly punctured his thumb.The employee went to the hospital emergency room where he was given an oral antibiotic.He returned to work.

Manufacturer Narrative

Without lot number it is not possible to provide expiration date.The shelf life of the product is 21 months.To penetrate a tissue or substance.Issue associated with small pieces of the device breaking off unexpectedly.Device problems caused by the separation of a component, object, or material into two or more pieces including shear.

• Brand Name: 3M ATTEST SUPER-RAPID READOUT BIOLOGICAL INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL STERILIZATION
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave.; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY; 601 22nd ave. south; brookings SD 57006
• Manufacturer Contact: linda johnsen ; 3m center, bldg. 275-5w-06; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 4054055
• MDR Text Key: 4730228
• Report Number: 2110898-2014-00063
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/13/2014

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 Catalogue Number: 1492V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 40 YR