MAUDE Adverse Event Report: 3M HEALTH CARE ATTEST SUPER RAPID 5 STEAM-PLUS; INDICATOR, BIOLOGICAL STERLIZATION, FRC (CFR880.2800)

Catalog Number 41482V

Device Problem Material Separation (1562)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 03/12/2015

Event Type  Injury  

Event Description

A supervisor of the hosp sterile processing dept reported that a female employee crushed an attest indicator vial in the autoreader after allowing the vial to cool for a few minutes.The employee pushed down on the vial cap with her thumb.She alleged a cut from the glass vial.The employee was instructed to go to the hosp employee health dept, where she was given prophylactic oral antibiotic.

Manufacturer Narrative

Information was received on this day indicating the type of medical intervention which is not typical for this type of reported event.Issue associated with an undesired disassociation or breaking apart of device materials.Conclusion: a device problem related to the operator's technique or use environment.This product is undergoing a redesign of the cap to minimize this type of event from occurring which may result in low risk of occurrence and minor injury when excessive force is used to crush the cap.

• Brand Name: ATTEST SUPER RAPID 5 STEAM-PLUS
• Type of Device: INDICATOR, BIOLOGICAL STERLIZATION, FRC (CFR880.2800)
• Manufacturer (Section D): 3M HEALTH CARE; st. paul MN 55144
• Manufacturer Contact: linda johnsen ; 3m center, bldg. 275-5w-06; st. paul, MN 55144-1000 ; 6517374376
• MDR Report Key: 4698692
• MDR Text Key: 5677960
• Report Number: 2110898-2015-00016
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/24/2015

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: Lay User/Patient
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 41482V
• Device Lot Number: 2016-10 WD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3M ATTEST AUTOREADER